Patient therapy systems and methods

ABSTRACT

Some embodiments include a system with a sensor with electrodes including an active electrode and a receiving electrode that is in physical contact with skin of a patient forming an electrical circuit with control electronics of a controller that can measure an electrical parameter using an active electrode and a receiving electrode within a closed loop electrical muscle stimulation system. A sense electrical pulse can be applied to the tissue using the sensor, an electrical parameter measured from the tissue, and a stimulation pulse applied to the tissue based at least in part on the measured electrical parameter. The stimulation is adjustably controlled by the controller to maintain a constant power output to the tissue based on the electrical parameter. A good is coupled to a computer readable medium configured to store usage data, the usage data relating to the patient&#39;s use of the good.

RELATED APPLICATIONS

This application is a Continuation-in-Part Application of U.S. patentapplication Ser. No. 15/007,014, filed on Jan. 26, 2016, and publishedas United States Patent Publication 20160213924A1, which claims priorityfrom U.S. Provisional Application No. 62/107,954, filed on Jan. 26,2015, and U.S. Provisional Application No. 62/170,001 filed on Jun. 2,2015, the entire contents of which are incorporated herein by reference.

BACKGROUND

Orthopedic braces and wraps are useful as preventative aids to preventinjuries to joints caused by motions or orientations of the joint thatare outside the biomechanical limits of the joint. Orthopedic braces andwraps are also useful to promote proper healing of a joint following aninjury to, or surgery on, the joint, and can be used to stabilize jointswith arthritis, thereby alleviating pain.

A critical part of the successful healing process after an injury andpotential surgery is the rehabilitation process. As a primary part ofthe rehabilitation process, patients usually see a physical therapist toregain range of motion as well as strengthen their muscle(s) aftersuffering an injury, undergoing surgery, or when afflicted witharthritis, conditions which can result in muscle atrophy. Knee braces inparticular are widely used to treat a variety of knee infirmities. Suchbraces may be configured to impart forces or leverage on the limbssurrounding the knee joint in order to relieve compressive forces withina portion of the knee joint, or to reduce the load on that portion ofthe knee. Moreover, in the event that knee ligaments are weak and infirmor surgically repaired, a knee brace may stabilize, protect, support, orrehabilitate the knee. Typical knee braces and the prescribing of kneebraces have several significant limitations and drawbacks. First, afteran injury occurs and a medical professional such as a physicianrecommends the patient wear a knee brace, the medical professional maynot see the patient again for several weeks to months after the initialvisit. The medical professional may not receive any feedback about rangeof motion of the joint or strength of the muscles surrounding the joint.

If the patient has been fitted with a brace, the physical therapist maymanually adjust the brace, under the guidelines provided by thephysician, in order to reduce or increase the allowed motion of theinjured joint, or to adjust a brace that has become loose secondary tomuscle atrophy, or both. These manual adjustments often lead to errors,as the adjustments are based on the personal judgments of the physicaltherapist (or medical professional), e.g., the muscles and surroundingtissues may not be of sufficient strength to support the joint.

In some cases, the patient may receive electrical muscle stimulation(EMS) at the start of the physical therapy process to regain the abilityto voluntarily contract their muscles before exercising and stretchingbegins. EMS, also known as neuromuscular electrical stimulation(“NMES”), has been used in therapeutic practice virtually unchanged inthe last 30 years. The current use model is to take a target musclegroup and provide electrical stimulation to mimic the action potentialsnormally created from neurological signals into order to activate andelicit an action potential and resultant contraction of the musclefibers causing the muscle to contract. The electrical stimulationtherapy can be enhanced by determining the appropriate level of powerand/or duration of the electrical pulse, the pulse width, the phasecharacteristics (monophasic, biphasic, triphasic, polyphasic,symmetric), frequency, waveform shapes (sinusoidal, square, triangular,trapezoidal, sawtooth, custom), duty cycle, work cycle on/off times,work cycle ramp type. EMS is also used by the therapist (as prescribedby the health care provider) to strengthen muscles which have atrophied.However, the delivery of EMS for muscle strengthening is sub-optimal, asit is usually performed when the patient is with the therapist. Further,a physician (e.g., surgeon) treating a patient often sees the patientseveral times after the treatment of the injury (e.g., surgery). Thephysician typically determines the next step in the patient's treatmentbased on how the patient looks and feels during a visit. The physician,however, usually does not have objective data associated with thepatient's injury to help in the physician's assessment of the patientand the next step in the patient's treatment. Specifically, thephysician may not be able to obtain accurate range of joint motion ormuscle strength. As a result, the physician often determines thepatient's next course of treatment based on his or her subjectiveanalysis of the patient at the time of the patient's visit; thisanalysis may be sub-optimal. In addition to the data being sub-optimal,the time points at which these data are observed is inefficient andsub-optimal. The patient may heal faster or slower than a typicalpatient and the patient's treatment may be able to be better customizedto his/her actual progress.

Thus, there remains a need for a brace system that can providemonitoring of the brace system in use, and provide feedback andadjustment (preferably in real time) of the brace system during a courseof therapy.

SUMMARY

Some embodiments of the invention include a system comprising at leastone sensor comprising a plurality of electrodes including at least oneactive electrode and at least one receiving electrode, the at least onesensor configured and arranged to be in physical contact with skin of apatient forming an electrical circuit with control electronics of atleast one controller. The electrical circuit is configured and arrangedto measure an electrical parameter using the at least one activeelectrode and at least one receiving electrode, and to form a closedloop electrical muscle stimulation system, where a stimulation currentor voltage applied by the sensor onto the skin between the at least oneactive electrode and at least one receiving electrode is based on atleast one program and at least one electrical parameter measured throughthe at least one active electrode and at least one receiving electrode.In some embodiments, the at least one controller is configured andarranged for (a) applying a sense electrical pulse to the tissue usingthe at least one sensor, (b) measuring the at least one electricalparameter from the tissue, (c) using at least one of the activeelectrodes, adjustably applying a stimulation pulse to the tissue basedat least in part on the measured electrical parameter, the stimulationbeing adjustably controlled by the at least one controller to maintain aconstant power output to the tissue based at least in part on the atleast one electrical parameter, and (d) repeat steps (a)-(c). Someembodiments include a good coupled to at least one computer readablemedium configured to store usage data, the usage data relating to thepatient's use of the good.

Some embodiments include a computing program, applet or applicationconfigured to upload usage data for analysis. In some embodiments, atleast one controller is configured and arranged to electromagneticallycouple with a mobile computing device using at least a portion of thecomputing program, applet or application. In some embodiments, at leasta portion of the computing program, applet or application is configuredand arranged to include at least one user interface on a user'scomputing device, and the at least one user interface configured todisplay at least some usage data and to enable control of a parameter ofthe good.

In some embodiments, at least one controller is configured to update theat least one user interface with at least one of a status of a portionof the good, a position of a portion of the good, and data from the atleast one sensor. In some embodiments, at least one user interfacecomprises a display including an option to scan and synchronize the goodwith the at least one controller. Some embodiments include at least oneuser interface comprising a display including an option to scan andsynchronize more than one good. In some further embodiments, the atleast one user interface comprises a display including an option toactivate a wired or wireless link to connect the good with the at leastone controller. In other embodiments, the display is configured andarranged to enable the user to set or reconfigure the at least onestimulation pulse.

Some embodiments include a display configurable by the at least aportion of the computing program, applet or application to display oneor more parameters related to at least one of stimulation provided by atleast a portion of the good, and a range of motion measured by at leasta portion of the good. In some embodiments, the display is configurableby the at least a portion of the computing program, applet orapplication to provide a visual representation of an action of a userwearing at least a portion of the good that is related to at least oneof stimulation provided by at least a portion of the good, and a rangeof motion measured by at least a portion of the good.

Some embodiments include a system where the computing device comprisesat least one of a desktop computer, a laptop computer, a digital tablet,a digital assistant, a cellular or smart phone, a smart watch, awearable activity monitor, a pair of glasses, a camera, a pager, and aninternet appliance. In some embodiments, the good comprises a braceassembly. In some embodiments, the brace assembly comprises at least oneof a brace, a stay, a sleeve, a band, a sling, a garment, a wrap, and astrap.

In some embodiments, the at least one sensor comprises an accelerometer,a motion sensor, a proximity sensor, an optical sensor, a motion sensor,a gyrometer, a magnetometer, a proximity sensor, a hydration sensor, aforce or pressure sensor, a position sensor, a global positioning sensor(GPS), an optical sensor, a magnetic sensor, a magnetometer, aninductive sensor, a capacitive sensor, an eddy current sensor, aresistive sensors, a magneto-resistive sensor, an inductive sensor, aninfrared sensor, an inclinometer sensor, a piezoelectric materials orpiezoelectric-based sensor, a blood-oxygen sensor, a heart-rate sensor,a laser or ultrasound based sensor, and/or an electromyography typesensor.

Some embodiments include a remote server including a computing program,applet or application configured to initiate or maintain an exchange ofthe usage data between the good and the server and/or a coupled mobilecomputing device and the server. In some embodiments, the server isconfigured as a host to a web portal or coupled to a host serverproviding the web portal, the web portal configured to access or displaythe usage data or at least one parameter related to use of at least aportion of the good.

In some embodiments of the invention, the web portal is configurable tocreate one or more alerts based on at least one user customizationcriteria related to the usage data, where the criteria can include alevel of use of at least a portion of the good by a user, a limit of useof at least a portion of the good by the user, a time of use of at leasta portion of the good by the user, a type of use of at least a portionof the good by the user, and/or a behavior of at least a portion of thegood while in use by the user.

In some embodiments, the alert comprises at least one of an email, atext or SMS message, a displayed icon, rendered text, a renderedgraphic, a categorized or customized alert. In some further embodiments,the at least one user customization criteria includes at least one of amonitoring window, usage rate and/or activity level, one or morespecified compliance or rehabilitation goals, compliance rate, range ofmotion (ROM), and pain values.

DESCRIPTION OF THE DRAWINGS

FIG. 1A is a representation of a knee brace including two sets ofgeometry with each coupled to one hard segment for the joint accordingto one embodiment of the invention.

FIG. 1B shows a knee brace including stays and wrap components inaccordance with some embodiments of the invention.

FIG. 1C illustrates range of motion data capture from a brace and bracesensors for motion capture in accordance with accordance with someembodiments of the invention.

FIG. 1D illustrates part of a knee wrap in accordance with someembodiments of the invention.

FIG. 1E illustrates a knee wrap in accordance with some embodiments ofthe invention.

FIG. 1F illustrates a brace system comprising a combined modularorthopedic brace and conductive wrap in accordance with some embodimentsof the invention.

FIG. 1G illustrates a combined modular orthopedic brace and conductivewrap in side view in accordance with some embodiments of the invention.

FIG. 2A illustrates a shoulder sling in accordance with some embodimentsof the invention.

FIG. 2B illustrates a wrist brace including a plurality of sensors inaccordance with some embodiments of the invention.

FIG. 2C illustrates a rear view of a full shoulder vest in accordancewith some embodiments of the invention.

FIG. 2D illustrates a rear view of a full shoulder vest in accordancewith some embodiments of the invention.

FIG. 2E illustrates a front view of a full shoulder vest in accordancewith some embodiments of the invention.

FIG. 2F illustrates a full shoulder vest showing an integrated sling inaccordance with some embodiments of the invention.

FIG. 2G illustrates a full shoulder vest showing an electrodecompression strap in accordance with some embodiments of the invention.

FIG. 2H illustrates a full shoulder vest showing midline vest closure inaccordance with some embodiments of the invention.

FIG. 2I illustrates a full shoulder vest showing an electrode access andtrapezious compression strap in accordance with some embodiments of theinvention.

FIG. 2J illustrates a rear view of a half vest in accordance with someembodiments of the invention.

FIG. 2K illustrates a close-up rear view of a half vest in accordancewith some embodiments of the invention.

FIG. 2L illustrates a front view of a half vest in accordance with someembodiments of the invention.

FIG. 2M illustrates a side front perspective view of a half vest inaccordance with some embodiments of the invention.

FIGS. 2N and 2P illustrate an air bladder in accordance with someembodiments of the invention.

FIG. 2Q illustrates an arm brace including a plurality of accelerometersensors in accordance with some embodiments of the invention.

FIG. 2R illustrates a calf brace 470 including a plurality ofaccelerometer sensors in accordance with some embodiments of theinvention.

FIG. 2S illustrates an ankle brace including a plurality ofaccelerometer sensors in accordance with some embodiments of theinvention.

FIG. 2T illustrates an inner region of a brace showing two contactpoints used to determine if the brace is being worn by a human inaccordance with some embodiments of the invention.

FIG. 2V illustrates a front view of a hip brace assembly with integratedsensors in accordance with some embodiments of the invention.

FIG. 2W illustrates a side view of a hip brace assembly with integratedsensors in accordance with some embodiments of the invention.

FIG. 2X illustrates a rear view of a hip brace assembly with integratedsensors in accordance with some embodiments of the invention.

FIG. 2Y illustrates a front view of an abdominal/back device withintegrated sensors in accordance with some embodiments of the invention.

FIG. 2Z illustrates a rear view of an abdominal/back device withintegrated sensors in accordance with some embodiments of the invention.

FIG. 3A shows a representation of wireless collection of data includingcellular data from a knee brace in accordance with some embodiments ofthe invention.

FIG. 3B depicts wireless data transfer data between a knee brace and acontroller in accordance with some embodiments of the invention.

FIG. 4 illustrates a computer system controller in accordance with someembodiments of the invention.

FIG. 5 illustrates a computer system including a backend server inaccordance with some embodiments of the invention.

FIG. 6 illustrates an image of screen showing the current status of abrace including a representation of the degree of flexure andorientation relative to the ground in accordance with some embodimentsof the invention.

FIG. 7 shows a representation of a brace system with kinematic datacollection sensors in accordance with some embodiments of the invention.

FIGS. 8-9 each provide representations of potential motion of variousportions of a brace system that can be monitored in the brace systemrepresented in FIG. 7 in accordance with some embodiments of theinvention.

FIG. 10 illustrates a sensor assembly for surface edema detectionthrough optical sensing in accordance with some embodiments of theinvention.

FIG. 11 illustrates a system for non-narcotic pain relief usingelectrical stimulation therapy to override pain impulses in accordancewith some embodiments of the invention.

FIG. 12 illustrates biological feedback data collection in accordancewith some embodiments of the invention.

FIG. 13 illustrates a smart electrode in accordance with someembodiments of the invention.

FIGS. 14A-14C illustrate adaptive electrodes in accordance with someembodiments of the invention.

FIG. 15 illustrates an NMES post-operative oscilloscope scan of pulsetrains in accordance with some embodiments of the invention.

FIG. 16 illustrates an NMES post-operative oscilloscope scan of achannel's individual pulses in accordance with some embodiments of theinvention.

FIG. 17 illustrates an NMES post-operative oscilloscope scan of achannel's individual pulses in accordance with some embodiments of theinvention.

FIG. 18 illustrates an NMES strength oscilloscope scan of pulse trainsin accordance with some embodiments of the invention.

FIG. 19 illustrates an NMES strength oscilloscope scan of a channel'sindividual pulses in accordance with some embodiments of the invention.

FIG. 20 illustrates an NMES strength oscilloscope scan of a channel'sindividual pulses in accordance with some embodiments of the invention.

FIG. 21 illustrates a TENS oscilloscope scan of a pulse train inaccordance with some embodiments of the invention.

FIG. 22 illustrates a TENS oscilloscope scan of individual pulses inaccordance with some embodiments of the invention.

FIG. 23 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 24 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 25 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 26 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 27 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 28 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 29 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 30 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 31 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 32 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 33 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 34 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 35 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 36 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 37 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 38 illustrates a display portion of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 39 illustrates a display portion of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 40 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 41 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 42 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 43 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 44 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 45 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 46 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 47 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 48 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 49 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 50 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 51 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 52 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 53 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 54 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 55 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 56 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 57 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 58 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 59 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 60 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 61 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 62 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 63 illustrates a display of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 64 illustrates a portion of a stimulation circuit of a therapycontrol system in accordance with some embodiments of the invention.

FIGS. 65A, 65B, and 66-74 illustrate various displays of a therapysystem control GUI in accordance with some embodiments of the invention.

FIG. 75 illustrates a therapy system in accordance with some embodimentsof the invention.

FIG. 76 illustrates data types for the therapy system of FIG. 75 inaccordance with some embodiments of the invention.

FIG. 77 illustrates data categories exchanged between and stored withincomponents of the therapy system of FIG. 75 in accordance with someembodiments of the invention.

FIG. 78 illustrates a portion of a provider portal dashboard inaccordance with some embodiments of the invention.

FIG. 79 illustrates a customizable panel and alerts window of theprovider portal dashboard in accordance with some embodiments of theinvention.

FIG. 80 illustrates a provider portal patient list window in accordancewith some embodiments of the invention.

FIG. 81 illustrates a patient overview window in accordance with someembodiments of the invention.

FIG. 82 illustrates a tabular view of a patient overview window inaccordance with some embodiments of the invention.

FIGS. 83A-83B, and 84A-84B illustrate patient overview printable chartsin accordance with some embodiments of the invention.

FIG. 85 illustrates a patient stimulation detail window in accordancewith some embodiments of the invention.

FIG. 86 illustrates a patient range-of-motion (ROM) detail window inaccordance with some embodiments of the invention.

FIGS. 87-88 illustrate patient pain detail windows in accordance withsome embodiments of the invention.

FIG. 89 illustrate patient passive range of motion (PROM) n accordancewith some embodiments of the invention.

FIG. 90A illustrates start mobile application screen in accordance withsome embodiments of the invention.

FIG. 90B illustrates scan mobile application screen in accordance withsome embodiments of the invention.

FIG. 90C illustrates an information mobile application screen inaccordance with some embodiments of the invention.

FIG. 91A illustrates a start stimulation mobile application screen inaccordance with some embodiments of the invention.

FIG. 91B illustrates a dashboard mobile application screen in accordancewith some embodiments of the invention.

FIG. 92A illustrates a stimulator session start mobile applicationscreen in accordance with some embodiments of the invention.

FIG. 92B illustrates a pain survey mobile application screen inaccordance with some embodiments of the invention.

FIG. 92C illustrates a stimulation treatment mobile application screenin accordance with some embodiments of the invention.

FIG. 93A illustrates a stimulation level information mobile applicationscreen in accordance with some embodiments of the invention.

FIGS. 93B-93C, and 94A illustrate stimulation level mobile applicationscreens in accordance with some embodiments of the invention.

FIG. 94B illustrates a stimulation information mobile application screenin accordance with some embodiments of the invention.

FIG. 95A illustrates a range of motion (ROM) start mobile applicationscreen in accordance with some embodiments of the invention.

FIG. 95B illustrates a range of motion (ROM) connecting mobileapplication screen in accordance with some embodiments of the invention.

FIGS. 95C and 96A illustrate a range of motion (ROM) measuring mobileapplication screen in accordance with some embodiments of the invention.

FIG. 96B illustrates a range of motion (ROM) results mobile applicationscreen in accordance with some embodiments of the invention.

FIG. 97A illustrates a settings mobile application screen in accordancewith some embodiments of the invention.

FIG. 97B illustrates a profile mobile application screen in accordancewith some embodiments of the invention.

FIG. 97C illustrates a set your goals mobile application screen inaccordance with some embodiments of the invention.

FIG. 98 illustrates a stimulation help mobile application screen inaccordance with some embodiments of the invention.

DETAILED DESCRIPTION

Before any embodiments of the invention are explained in detail, it isto be understood that the invention is not limited in its application tothe details of construction and the arrangement of components set forthin the following description or illustrated in the following drawings.The invention is capable of other embodiments and of being practiced orof being carried out in various ways. Also, it is to be understood thatthe phraseology and terminology used herein is for the purpose ofdescription and should not be regarded as limiting. The use of“including,” “comprising,” or “having” and variations thereof herein ismeant to encompass the items listed thereafter and equivalents thereofas well as additional items. Unless specified or limited otherwise, theterms “mounted,” “connected,” “supported,” and “coupled” and variationsthereof are used broadly and encompass both direct and indirectmountings, connections, supports, and couplings. Further, “connected”and “coupled” are not restricted to physical or mechanical connectionsor couplings.

The following discussion is presented to enable a person skilled in theart to make and use embodiments of the invention. Various modificationsto the illustrated embodiments will be readily apparent to those skilledin the art, and the generic principles herein can be applied to otherembodiments and applications without departing from embodiments of theinvention. Thus, embodiments of the invention are not intended to belimited to embodiments shown, but are to be accorded the widest scopeconsistent with the principles and features disclosed herein. Thefollowing detailed description is to be read with reference to thefigures, in which like elements in different figures have like referencenumerals. The figures, which are not necessarily to scale, depictselected embodiments and are not intended to limit the scope ofembodiments of the invention. Skilled artisans will recognize theexamples provided herein have many useful alternatives and fall withinthe scope of embodiments of the invention.

FIG. 1A is a representation of a knee brace 100 with one or more stayscoupled to a user (where a user's leg is shown in the representation).In some embodiments, the knee brace 100 can comprise a stay 105 movablecoupled to a stay 110 through a pivot region 115. When positioned assuch, the knee brace 100 includes two sets of geometry where the stay105 can be free to move with respect to the stay 110 pivoting and/ormoving about the pivot region 115. In some embodiments of the invention,the knee brace 100 and any of the brace systems or assemblies disclosedherein can comprise systems and methods for determining positional dataof any component or portion of the brace system. For example, in someembodiments, one or more sensors can be integrated or coupled to atleast a portion of the brace system and used to measure or monitor userparameters, track the functional characteristics of the brace system,and/or monitor the environment of the user. In some embodiments, one ormore sensors can be integrated with or coupled to at least a portion ofthe brace system and used to measure absolute or relative positionand/or movement of any portion of the brace system while attached to theuser. In some embodiments, a wrap can be used without a brace and canfully support the sensors and other components disclosed herein as beingcoupled to a brace. In some embodiments, one or more sensors can beadded to any rigid portion of the brace system. For example, in someembodiments, knee brace 100 can include at least one sensor coupled toat least one of the stays 105, 110. For example, in some embodiments,the knee brace 100 can include a sensor 120 coupled to the stay 105. Insome further embodiments, the knee brace 100 can include a sensor 125coupled to the stay 110. By way of their coupling to the stays 105, 110,sensors 120, 125 can include three-axis movement. Further, depending onthe user's movement, the sensors 120, 125 can each move independently ofeach other in three dimensions. In some embodiments, the stay 105 can becoupled to an upper portion 132 of a wrap 130 for positioning against,proximate or adjacent to the thigh of a user, and the stay 110 can becoupled to a lower portion 134 of a wrap 130 for positioning against,proximate or adjacent to the lower leg of a user. For example, FIG. 1Bshows the knee brace 100 including stays 105, 110 and wrap 130 inaccordance with some embodiments of the invention. In some embodiments,the wrap 130 can comprise a high-compression and non-slip material thatis breathable. In some embodiments, the sensors 120, 125 can measure theposition and/or movement and acceleration of any one of the sets ofgeometry of the brace 100 in any x, y, and/or z-axis. In someembodiments, the sensors 120, 125 can be coupled to an external surfaceof any portion of the brace 100, including for example to locationswithin the wrap 130 or stays 105, 110 system shown in FIG. 1B. In someembodiments, sensors can be integrated with the brace 100 by integratinginto an internal portion of the brace 100 or by coupling to an externalsurface of the brace 100.

In some embodiments of the invention, the sensors can include anaccelerometer. For example, in some embodiments, sensors can include oneor more small solid-state or micro-electromechanical systems (MEMS)accelerometers, gyroscopes, and/or magnetometers can be coupled to oneor more portions of the brace system and used to measure/sense positionand orientation, acceleration, velocity, vibration or shock along asingle or multiple axes. In some embodiments of the invention, thesensors can comprise at least one Hall effect sensor. In some furtherembodiments, the brace system can include one or more magnets coupled toportions of the brace system that can be used in combination with amagnetic sensor. For example, some embodiments of the invention cancomprise at least one Hall effect sensor can be used with one or moremagnets to determine motion of at least a portion of the brace system.For example, in some embodiments, the sensor can determine rotationrelative to a fixed point on a hinge of the brace system.

Some embodiments of the invention include brace systems or assembliesthat can capture range of motion (hereinafter “ROM”). In someembodiments, range of motion data can be used prior to surgery todetermine when the patient has recovered enough from an initial injurytrauma to undergo surgery, potentially indicating that swelling and softtissue mobility are at acceptable levels for surgery. In some furtherembodiments, range of motion data can be used after surgery to determinewhen the patient has recovered (and therefore can be used to determinethe rate of recovery from surgery). For example, FIG. 1C illustrates anexample of range of motion data capture from a brace system 140. In someembodiments, positional data can be added to any brace system 140 thathas one or more rigid structures to which one or more motion sensors canbe coupled. For example, in some embodiments, the brace system 140 caninclude a stay 145 including a coupled sensor 155, and the stay 150 caninclude a coupled sensor 160. In some embodiments, the brace sensors155, 160 can comprise one or more accelerometers, gyroscopes, and/orpositional encoders coupled to at least one rigid portion of the bracesystem. In some embodiments, as either one or both of the stays 145, 150moves, rotates or pivots about the coupling 170, the sensors 155, 160can be used to give active feedback to the patient about current rangeof motion. In some embodiments, range of motion data can be used tocontinually provide feedback to a user to encourage them to stretchmuscles or move a joint during a recovery phase. For example, in someembodiments, tactile feedback can be provided whenever a user hasexceeded a specified maximum range of motion. Further, in someembodiments, the brace system 140 can be used to warn a user when theyare hitting a range of motion that is not considered to be safe based onthe user's stage of recovery. In some other embodiments, the bracesystem 140 can incorporate dynamic resistance, spring rate, and/or forceor damping if high accelerations or ranges of motion are detected toprotect the joint. In some embodiments, this can be achieved usingmagneto-rheological fluids, inertia valve designs, piezoelectricsprings/materials, etc. Some embodiments of the invention includekinematic data collection sensors for measuring the position andmovement of a brace system 140. Further, in some embodiments, the bracesystem 140 can include range of motion sensors for any brace system thatincludes one or more hinge features. In some embodiments, the sensorscan include indexing points so that absolute position can be determined.Some embodiments of the invention can include proximity or contact basedsensors to determine where set points on a hinge are in proximity of thesensor. In some embodiments, the sensor can be an optical (shadow,self-imaging, or interferometric) sensor, a magnetic sensor, aninductive sensor, a capacitive sensor, an eddy current sensor, aresistive sensor, a magneto-resistive sensor, an inductive sensor, aninfrared sensor, an accelerometer sensor, an inclinometer sensor, apiezoelectric sensor, etc.

In some embodiments of the invention, any of the brace systems orassemblies disclosed herein can include one or more controllers. In someembodiments, the controllers can be integrated and/or coupled withstays, joints, pivots or wraps of the brace system. For example, in someembodiments of the invention, control electronics can include a pivotaljoint configured to enable a brace of the brace system to flex (e.g.,during the patient's flexion and extension). The pivotal joint caninclude a solenoid and an accelerometer to lock the brace (e.g., aftersensing a stress). In one embodiment, the pivotal joint includes adigital positional encoder to determine an absolute position of thejoint. The positional encoder can enable adjustment of the physicalresistance applied to the joint when the patient moves the joint. Thebrace control electronics can include a communication module (e.g.,transmitter or transceiver or wire) for communicating with the computingdevice.

Some embodiments include dynamic bracing systems with integratedelectrical stimulation that can be configured for assisting in achievingjoint flexion and/or extension. In some embodiments, one or more linearsprings, torsion springs, and/or cam-based systems can be used toprovide dynamic bracing options. In some embodiments, the brace systemcan comprise a hip brace with integrated electrical stimulation forproviding LAMES therapy to targeted tissue in the pelvic region.

In some embodiments, one or more sensors can be integrated into awearable wrap or garment. For example, FIG. 1D illustrates part of aknee wrap 180, and FIG. 1E illustrates a knee wrap 180 in accordancewith some embodiments of the invention. As illustrated, in someembodiments, the knee wrap 180 can comprise a main body wrap 185 thatincludes a non-slip compression material 187. In some embodiments, thismaterial can assist in preventing movement of the knee wrap 180 whenpositioned on the wearer through friction and compression force. In someembodiments, the main body wrap 185 can include various extensions 189to enable wrapping and attachment of the wrap 180 to the knee of theuser, and can include various apertures to accommodate various portionsof the wearer's body. For example, in some embodiments, the knee wrap180 can include a popliteal cutout 191 to accommodate the structure andmovement in the vicinity of the back of the wearer's knee. Further, insome embodiments, various electronics can be coupled to or integratedwith the main body wrap 185. For example, in some embodiments, the mainbody wrap 185 can include one or more stimulation electrode or electrodepairs 195 such as quadriceps electrodes 195 a and/or calf electrodes 195b. Moreover, in some embodiments, the electrode or electrode pairs 195can be positioned on the inner surface 181 of the wrap 180 to enablecontact with the skin of a wearer. As used herein, each stimulatingelectrode pair can comprise a first electrode structure having a firstpolarity, and a second electrode structure having a second polarity. Thefirst and second polarities can be different so that the first andsecond electrode structures function to form an electrode pair capableof electrical stimulation. In some embodiments, the structure of thefirst electrode can be substantially the same or similar to the secondelectrode. In other embodiments, the structures of the first and secondelectrodes can be different. In some embodiments, the electrodes are notlimited to conventional electrode structures. For example, in someembodiments, one or more electrodes can comprise conductive materialcapable of transmitting signals efficiently or, in some embodiments,with significant loss or degradation while still providing sufficientsignal strength for the particular application. As used herein, theterms “stimulating electrode” and “stimulating electrode pair” can beused interchangeably.

In some embodiments, one or more brace assemblies can be integratedand/or coupled to a knee wrap to form a combined modular orthopedicbrace and conductive wrap. For example, FIG. 1F illustrates a bracesystem 200 comprising a combined modular orthopedic brace 210 andconductive wrap assembly 220 in accordance with some embodiments of theinvention, and FIG. 1G illustrates a combined modular orthopedic brace210 and conductive wrap assembly 220 in side view in accordance withsome embodiments of the invention. In some embodiments of the invention,for positioning, compression, and comfort, the wrap assembly 220 caninclude brace straps 230, malleolus pads 235, and a slide lock 240.Further, in some embodiments, a stimulation module 250 can be coupled tothe assembly 220 to enable application of stimulation therapy. Further,in some embodiments, the assembly can include a dial hinge 245 with ROMstops to enable customized fitting and therapy.

Some embodiments include brace systems or assemblies configured fortargeted regions of the wearers body. For example, FIG. 2A illustrates ashoulder sling 300 in accordance with some embodiments of the invention.In some embodiments, the shoulder sling 300 can include a wrap orpartial garment 301 that wraps or encloses at least a portion of awearer's body including at least a shoulder region. In some embodiments,the shoulder sling 300 can include electrodes on the inside that can beused to stimulate the rotator cuff muscles (e.g. supraspinatus,infraspinatus, etc., parascapular muscles, other muscle groups, and/orthe shoulder joint). For example, in some embodiments, the shouldersling 300 can include electrodes 305 coupled or integrated with thesling 300. Further, in some embodiments, the sling 300 can include atleast one accelerometer that can measure, monitor, or track movement ofthe wearer, including movement of the wearer's shoulder with respect totheir torso. For example, in some embodiments, the sling 300 can includean accelerometer 310 positioned at one end of the sling 300 near thehead or neck end of the wearer. In some further embodiments, the sling300 can include an accelerometer 310 positioned at one end of the sling300 near, adjacent or proximate the shoulder or arm of a wearer.

FIG. 2B illustrates a wrist brace 320 comprising a wrap 325 configuredto at least partially wrap or enclose the wrist and/or hand of a wearer.In some embodiments, the wrist brace 320 can include a plurality ofsensors 330. In some embodiments, the sensors can include one or moreaccelerometers. In some further embodiments, other types of sensors canbe included such as motion sensors, proximity sensors, optical sensors,magnetic sensors, inductive sensors, capacitive sensors, eddy currentsensors, resistive sensors, magneto-resistive sensors, inductivesensors, infrared sensors, inclinometer sensors, piezoelectric materialsand piezoelectric-based sensors, etc. In some embodiments, the wristbrace 320 can also include electrodes 335 positioned on the inside ofthe wrap 325 that can be configured to stimulate distal arm musclegroups and/or the wrist joint(s).

Some embodiments include wraps, braces, or vests that include integratedsupport and/or tension members. In some embodiments, the tension orsupport members can function to provide support and/or to impart tensionto the wrap, brace, or vest. For example, FIG. 2C illustrates a rearview of a full shoulder vest 350 in accordance with some embodiments ofthe invention. In some embodiments, the vest 350 can include one or moreinternal tension members 355. In some embodiments, one or more of thetension members 355 can function to provide a mechanical force to thebody of a wearer (e.g., such as the shoulders of a wearer) in order tocorrect posture. In some embodiments, the vest 350 can includefunctional electrodes for posture. For example, FIG. 2D illustrates arear view of the full shoulder vest 350 in accordance with someembodiments of the invention, and FIG. 2E illustrates a front view ofthe full shoulder vest 350 in accordance with some embodiments of theinvention. In some embodiments, the vest 350 can comprise a main vestbody 351 that can be closed using one or more closure extensions 372. Insome embodiments, the vest 350 can include paraspinal/scapula stabilizerelectrodes 362 for posture. Further, some embodiments can include an airbladder pocket 364 including at least one air bladder configured forsleeping support and electrode compression.

FIGS. 2N and 2P illustrate an air bladder 425 that can be used invarious embodiments of the invention described herein. In someembodiments, the air bladder 425 can comprise at least one reversiblyinflatable bladder 430 coupled to an inflation assembly 433. In someembodiments, the inflation assembly 433 can comprise a detachableinflation tube 440, and a deflation valve 438 coupled to a pump 435(e.g., a manual pump). In some other embodiments, the vest 350 can alsoinclude integrated heat or cold therapy by inserting or attaching a heator ice pack into a pocket or underneath the shoulder area of the vest,against the patient's skin. Further, some embodiments provide anintegrated sling support 358 for the wearer.

Various views of the full shoulder vest 350 shown illustrated on awearer can be seen in FIGS. 2F-2I. For example, FIG. 2F illustrates afull shoulder vest 350 showing an integrated sling 358 in accordancewith some embodiments of the invention. FIG. 2G illustrates a fullshoulder vest 350 showing an electrode compression strap 368 andapproximate location of a compressed electrode 360, and FIG. 2Hillustrates a full shoulder vest 350 showing midline vest closureincluding closure extensions 372 in accordance with some embodiments ofthe invention. FIG. 2I illustrates a full shoulder vest 350 showing anelectrode access and trapezious compression strap 368 a in accordancewith some embodiments of the invention. In some embodiments, the strap368 comprises the strap 368 a.

Some embodiments include vests that cover other regions of a wearer'supper body. For example, some embodiments include a vest that covers apartial region (e.g., a left-side, right-side, or central region) of awearer's torso. For example, FIG. 2J illustrates a rear view of a halfvest 380 in accordance with some embodiments of the invention. Further,FIG. 2K illustrates a close-up rear view of the half vest 380, and FIG.2L illustrates a front view of the half vest 380 in accordance with someembodiments of the invention. Similar to the full vest 350 describedearlier, some embodiments can include one or more electrical stimulationelectrodes 386. In some embodiments, the half-vest 380 can include oneor more air bladder pockets 390. Some embodiments include at least onecompression strap. For example, as shown in FIG. 2L, in someembodiments, the half-vest 380 can include a trapezius compression strap384 coupled to a torso wrap 382. The half-vest 380 can also include anintegrated sling 388 coupled to the torso wrap 382. Some embodimentsinclude at least one electrode access opening 400. Further, someembodiments can include at least one strap or pocket configured to holdor support a portion of the wearer's body. For example, some embodimentsinclude an adjustable quarterback pocket 395 coupled to or integratedwith the half-vest 380. Further, FIG. 2M illustrates a side frontperspective view of a half vest 380 in accordance with some embodimentsof the invention. In some embodiments, the vest 380 can comprise atleast one strap or fastener 405 that can be used by a wearer to securethe vest, tighten the vest, loosen the vest, or remove the vest.

Further, in some embodiments, the vest can include at least onestimulation module 410. In some embodiments, one or more stimulationmodules 410 can be integrated into the vest 380. In some furtherembodiments, one or more stimulation modules 410 can be reversiblysecured to the vest using a variety of attachment mechanisms including,but not limited to fasteners, clips, Velcro, buttons, snap-fit or snapon assemblies, etc.

FIG. 2Q illustrates an elbow brace 450 including a plurality ofaccelerometer sensors in accordance with some embodiments of theinvention. In some embodiments, the elbow brace can include electrodes455 on the inside of the brace 450 that can be used to stimulateproximal arm muscle groups, distal arm muscle groups, and/or the elbowjoint(s). In some embodiments, the electrodes 455 can be positioned inthe upper arm portion 452 of the brace 450 and/or the lower arm portion454 of the brace 450. In some embodiments, the brace 450 can include anaccelerometer 460 integrated or coupled to the upper arm portion 452,and an accelerometer 462 integrated or coupled to the lower arm portion454.

FIG. 2R illustrates a calf brace 470 including a plurality ofaccelerometer sensors in accordance with some embodiments of theinvention. In some embodiments, the calf brace 470 can comprise a wrap475 that can also include sensors and/or electrodes 480 on the inside ofthe brace 470 that can be used to stimulate distal leg muscle groups,and/or the knee joint(s), and/or ankle joint(s). In some embodiments,the electrodes 480 can be energized with electrical stimulation tostimulate the calf muscle groups to induce an electrical or mechanicalpumping effect that pumps bodily fluids such as blood to reduce edemaand prevent deep vein thrombosis (DVT).

FIG. 2S illustrates an ankle brace 500 comprising a wrap 501 including aplurality of accelerometer sensors in accordance with some embodimentsof the invention. In some embodiments, the ankle brace 500 can includeelectrodes 505 on the inside of the wrap 501 that can be used tostimulate distal leg muscle groups, and/or the ankle joint(s), and/orfoot joint(s). The brace 500 can include an accelerometer 510 in a legportion 503 of the wrap 501. In other embodiments, the brace 500 caninclude an accelerometer 515 in a foot portion 504 of the wrap 501.

In some further embodiments, one or more sensors can be coupled tovarious inner regions of the brace system. For example, FIG. 2Tillustrates an inner region of a brace showing two sensors positionedwithin the inner region of the brace system. In some embodiments,portions of the sensors can comprise contact points that are located andconfigured at the outer surface of the inner region of the brace system.In some embodiments, the sensors can comprise human contact sensors thatcan be used to determine if the brace is being worn by a human. In someembodiments, measurements from the sensors can be used to providepatient compliance data where usage of the brace system is monitored andlogged. In some other embodiments, the sensors can be used to monitor ifthe brace system is correctly positioned on the user. For example, insome embodiments, the brace 550 can comprise a main body portion 555 andupper and lower strap portions 557, 559. In some embodiments, the hipbrace 550 can include electrodes on the inside of one of the strapportions 557, 559 that can be used to stimulate muscle groups. Forexample, in some embodiments, strap portion 557 can include a pluralityof electrodes 560 positioned on various regions of the strap portion557. Further, in some embodiments, either or both of the strap portions557, 559 can include at least one contact sensor. For example, in someembodiments, the strap portion 557 can include at least one integratedor coupled contact sensor 565.

Some embodiments of the invention can include wraps, braces and/or vestsuitable for the hip region of a wearer. As with the aforementionedwraps, braces, and vest, some embodiments of a hip device can includevarious integrated or coupled sensors, electrodes, supports and/ortension members. For example, FIG. 2V illustrates a front view of a hipbrace assembly 570 with integrated sensors in accordance with someembodiments of the invention. FIG. 2W illustrates a side view of the hipbrace assembly 570. Further, FIG. 2X illustrates a rear view of the hipbrace assembly 570 with integrated sensors in accordance with someembodiments of the invention. In some embodiments, the hip braceassembly 570 can comprise an abdominal/back belt 575, a compressiveshort conductive garment 578, and a brace bar assembly 580. In someembodiments, the brace bar assembly 580 can comprise an upper bar 582and lower bar 584 coupled via a brace hinge 586. In some embodiments,the hip brace assembly 570 may also include electrodes on the insidethat can be used to stimulate proximal leg muscle groups, abductors,adductors, gluteal muscle groups and/or the hip joint. For example, insome embodiments, the hip brace assembly 570 can include abdominalelectrodes 577 integrated or coupled into the abdominal/back belt 575used to stimulate abdominal muscle groups, lower back muscle groups,and/or the back joint(s), and/or pelvic joint(s), and/or hip joint. Inother embodiments, the compressive short conductive garment 578 caninclude gluteal muscle groups stimulating electrodes 590.

In some further embodiments of the invention, the measurement ofposition, movement, and/or acceleration of a portion of a brace assemblycan be used to determine track the position and movement of the user.For example, in some embodiments, the assembly can be used to monitor auser to determine how much time the user spends in an upright positionand/or in a supine position. In some embodiments, acceleration data fromthe brace system can be computed on a per limb basis which can betallied as a running average. Further, in some embodiments, this averageacceleration value can be used to directly correlate to the amount thepatient is moving the limb, and can be used as key to identify adecrease in range of motion. For example, the lower the number, thelower the general level of movement of the user in total. In someembodiments, if the maximum flexion numbers received from the sensorsare high and the average acceleration value is very low, the user issitting in place flexing a limb. However, if the average accelerationvalue number is very high, and the maximum flexion numbers are low, theuser is moving around, but they are keeping the braced limb in a lockedposition with no movement at the joint. In some other embodiments, usingany of the integrated or coupled sensors or accelerometers disclosedherein, free fall incidents can be determined by the one or more sensorsof a brace assembly and reported to computer system (e.g., such as acoupled computer or server or backend system or mobile device asdisclosed herein). In some embodiments, the brace system can record thefree falls to denote any time the brace (and the user) have fallen.Further, in some embodiments, the brace system can determine the heightof the fall based on the duration and the rate of acceleration. In someembodiments, the brace system can determine if the user began to falland subsequently caught themselves. Moreover, in some embodiments, thebackend system can create and/or calendar a follow up requirement for amedical professional to determine if the fall did any damage. Referringto FIG. 2W, in some embodiments, the assembly 570 can includesensors/accelerometers 588 integrated and/or coupled with one or moreportions of the brace bar assembly 580 including for example with theupper bar 582 and/or the lower bar 584 and/or the brace hinge 586.

In some further embodiments of the invention, patient compliance dataobtained from the accumulated measurements from the sensors can bestored on a database (e.g., in a back-end computer system) and can beused by, for example, physicians or medical professionals to retrieve,review, and/or analyze the data from the brace system. In someembodiments, the physicians may utilize the data from the brace in thephysician's analysis or recommendations to the patient. Further,physicians may utilize the data from the brace system of one patient inrecommendations to other patients with similar conditions or injuries.For example, if the physician tells a patient recovering from an ACLreconstructive surgery to execute program 1 for the first week, and toexecute program 2 for the second week, and if the physician seessignificant improvements in the patient's strength in the patient's kneedue to these programs, the physician will likely tell another patientrecovering from a similar surgery to execute the same programs duringthe same time periods. In some embodiments, the physician can have theprograms for the second patient updated remotely via a wired or wirelessconnection to the Internet or a private network. The physician can thenobtain data from both patients to see how they are responding to thebrace system and the programs being executed by the brace system.

Some embodiments of the invention can include wraps, braces and/or vestsuitable for an abdominal/back region of a wearer. As with theaforementioned wraps, braces, and vest, some embodiments of theabdominal/back device can include various integrated or coupled sensors,electrodes, supports and/or tension members. For example, FIG. 2Yillustrates a front view of a abdominal/back device 600 with integratedsensors in accordance with some embodiments of the invention, and FIG.2Z illustrates a rear view of abdominal/back device 600 with integratedsensors in accordance with some embodiments of the invention. Someembodiments can include a main body 605 with a coupled or integratedbrace panel 610. In some embodiments, abdominal electrodes 615 can becoupled or integrated with the abdominal/back device 600. Further, someembodiments include an abdominal/back belt brace 620 coupled to the mainbody 605. In some embodiments, the abdominal/back belt brace 620 caninclude one or more coupled or integrated back electrodes 625. Further,similar to other embodiments described earlier, some embodiments of theabdominal/back device 620 can include one or more optional air bladdersfor electrode compression and/or back support.

In some embodiments of the invention, the various electronic componentscan be integrated into one or more modules of a brace system, and themodules can be combined and recombined into various configurations. Forexample, in some embodiments, some brace systems or assemblies cancomprise a set of modules each of which has a distinct function, and thecombination of which creates a general NMES platform with different userinterfaces and/or different sensors for data collection. In someembodiments, this platform can comprise at least one stimulation system,one or more sensor systems, and at least one display system. Further, insome embodiments, the brace system can be controlled by and/or transferdata through a controller in a wired or wireless fashion. For example,in some embodiments of the invention, any of the brace systems orassemblies described herein can be configured to transmit and/or receiveinformation wirelessly. For example, FIG. 3A shows a representation ofwireless brace system 630 configurable for wireless collection of datafrom a knee brace assembly 670 including data communicated through acellular 650 and/or a WiFi network 655 to a coupled or integratedcontroller 675 comprising a wireless antenna 675 a. In some embodiments,one or more portions of the knee brace assembly 670 can include one ormore sensors (e.g., an accelerometer or other sensor as discussedearlier) such as sensor 681 coupled to stay 682 and/or sensor 683coupled to stay 684 that can be coupled to the controller 675 to enablewireless transmission of data from and/or to the controller 676 and/orsensors 681, 683. In some embodiments, a graphical user interface (GUI)640 can be used to control and/or monitor the function of variousfunctional aspects of the wireless brace system 630, including any ofthe components in the system 630. In some embodiments, the controller675 can comprise a rechargeable power and control unit configured forstimulation and collection of sensor data.

In some embodiments, the controller 675 can manage sensing and/orstimulation of a patient wearing a brace system or garment (e.g., suchas wireless brace system 630). In some embodiments of the invention, thecontroller 675 can configured (a) apply at least one stimulation sensepulse to the patient's tissue using at least one sensor and/orelectrode, (b) measure at least one electrical parameter from thepatient's tissue related to power dissipation of the sense pulse in thetissue, (c) adjustably apply the at least one stimulation pulse to thepatient's tissue based at least in part on the measured powerdissipation. In some embodiments, the at least one stimulation pulse canbe adjustably controlled by the at least one controller to maintain aconstant power output to the patient's tissue based at least in part onthe at least one electrical parameter. In some embodiments, the steps(a) through (c) can be repeated at least once.

FIG. 3B depicts wireless data transfer data between the knee braceassembly 670 and the controller 675 in accordance with some embodimentsof the invention. In some embodiments, a wireless RF transmission fromthe brace system 670 can be of sufficient power to enable reliableoperation and transmission of data from the brace system with adequatebandwidth while minimizing tissue propagation characteristics andspecific absorption rate (to avoid tissue heating) and reduce exposureof the user to near-field and far-field RF transmission. In someembodiments, the brace system 670 can be configured to transmit and/orreceive an RF transmission including, but not limited to, a zerogeneration wireless signal, a first generation wireless signal, a secondgeneration wireless signal, a third generation wireless signal, a fourthgeneration wireless signal, a fifth generation wireless signal, anyglobal positioning satellite signal (such as “GPS” or “GLONASS”), anindustrial, scientific, and medical (ISM) frequency bands (e.g.,2400-2493.5 MHz), a Bluetooth® wireless signal (such as IEEE 802.15.4Bluetooth® class II), RFID electromagnetic radiation, a WiFi wirelesssignal, a two-way radio RF signal, a UHF or VHF signal (such as acitizen's band radio signal or other radio signal emitted from a‘walkie-talkie’ type device), high-speed and millimeter wave signals,and a near-field wireless signal. Bluetooth® is a computing andtelecommunications industry specification that details how mobiledevices can easily interconnect with each other and with non-mobiledevices using a short-range wireless connection. Bluetooth® is aregistered trademark of Bluetooth SIG, Inc.

In some embodiments, the controller 675 can comprise a computer systemor device. In some embodiments, the brace system can be configured tocommunicate (e.g., wirelessly or via a wired connection) with acomputing device that may perform the function of the controller 675.Examples of the computing device include, but are not limited to,personal computers, digital assistants, personal digital assistants,mobile phones, wearable technology devices (e.g. smart watches, activitymonitors, heart rate monitors, glasses, cameras, etc.), smartphones,tablets, or laptop computers. In some embodiments, the computing devicecan be the patient's device or a device associated with a medicalprofessional. Both types of devices can enable the medical professionalto retrieve and analyze data transmitted from the brace system. In oneembodiment, this data is transmitted in real-time, so that the medicalprofessional can analyze the data and/or adjust the brace at any time.For example, in some embodiments, the patient can access data using amobile application on his device. In some further embodiments, aphysician and/or therapist can access data via a web portal. In someembodiments, any data accessed through from any of the brace systemsdescribed herein, including any data collected or channel through acontroller such as controller 675 can be secured using one or moreconventional encryption methodologies. In some embodiments, theprotocols and method for data transfer as described are HIPAA compliant.

Referring to FIG. 4, in some embodiments, any of the brace systems orassemblies described herein can electronically couple with a computersystem 700 that can be configured to transfer data from and/or to thebrace system. Further, in some embodiments, the brace system can alsocomprise brace control electronics that can be configured to provide theLAMES via a program selected from a plurality of programs. In at leastone embodiment of the invention, the brace control electronics can beconfigured to receive, via a receiver, a selection of the program (e.g.,from the patient, from a medical professional, etc.). In one embodiment,the medical professional can prevent patient control of the brace (e.g.,for a period of time). Further, as illustrated in FIGS. 3A-3B, in someembodiments, a brace system (such as brace system 670) can communicatewith the computer system 700 using a controller, such as controller 675.In some embodiments, the controller 675 can function as an internettransceiver coordinating and routing data between the brace and thecomputer system 700. In some embodiments, the system 700 comprises thecontroller 675. In some embodiments of the invention, the computersystem 700 can be a local computer system (e.g., a computer systemwithin the user's home) that can be configured to receive and/or sendinformation to the brace system 670. In some embodiments, the computersystem 700 can include a bus 701 for communicating information betweenthe components in the computer system 700. Further, in some embodiments,at least one processor 702 can be coupled with the bus 701 for executingsoftware code, or instructions, and processing information. In someembodiments of the invention, the computer system 700 furthercompromises a main memory 704, which can be implemented using randomaccess memory (RAM) and/or other random memory storage devices. In someembodiments, the main memory 704 can be coupled to the bus 701 forstoring information and instructions to be executed by the processor702. Further, in some embodiments, the main memory 704 also can be usedfor storing temporary variables, NMES program parameters, or otherintermediate information during the execution of instructions by theprocessor 702. In some embodiments, the computer system 700 can alsoinclude a read only memory (ROM) and/or other static storage devicecoupled to the bus 701 for storing static information and instructionsfor the processor 702. In some embodiments of the invention, thecomputer system 700 can include one or more peripheral componentsenabling user interaction with the system 700. For example, in someembodiments, the system 700 can include a cursor control device 723,such as a conventional mouse, touch mouse, trackball, track pad, orother type of cursor direction keys for communicating directioninformation and command selection to the processor 702 and forcontrolling movement of a cursor on the display 721. Further, the system700 can also include at least one keyboard 722 for data input, andfacilitation of command and control of the various aspects of the system700, and at least one communication device 725 operatively coupled tothe processor 702 via the bus 701.

In some embodiments, any of the brace systems or assemblies describedherein (including the brace system 670) can be coupled to and transferdata from and/or to a computer system that is configured to receiveand/or send information to the brace system and any coupled computersystem. Turning to FIG. 5, in some embodiments, a computer system 800can comprise a backend system that can be used as a host computer forstoring information measured and sent by the brace system. In someembodiments of the invention, the information can be received and/orsent between the brace system and the computer system 800 using thecomputer system 700 (i.e., a local computer system and/or controllerthat can be configured to receive and/or send information to the bracesystem locally). In some further embodiments, the information can bereceived and/or sent between the brace system and the computer system800 directly (e.g., using a cellular wireless transmission). Further, insome embodiments, the brace can communicate with the computer system 800and the computer system 700 using a controller, such as controller 100.In some embodiments, the controller can function as an internettransceiver coordinating and routing data between the brace and thecomputer systems 700, 800.

In some embodiments of the invention, the system 800 can include atleast one computing device, including at least one or more processors820. In some embodiments, some processors 820 can include processors 820residing in one or more conventional server platforms. In someembodiments, the system 800 can include a network interface 850 a and anapplication interface 850 b coupled to at least one processors 820capable of running at least one operating system 840. Further, thesystem 800 can include the network interface 850 a and the applicationinterface 850 b coupled to at least one processor 820 capable ofprocessing one or more of the software modules 880 (e.g., one or moreenterprise applications). In some embodiments, the software modules 880can comprise a server-based software platform. In some embodiments, thesystem 800 can also include at least one computer readable medium 860.In some embodiments, at least one computer readable medium 860 can becoupled to at least one data storage device 870 b, and/or at least onedata source 870 a, and/or at least one input/output device 870 c.

In some embodiments, the invention can also be embodied as computerreadable code on a computer readable medium 860. In some embodiments,the computer readable medium 860 can be any data storage device that canstore data, which can thereafter be read by a computer system. Examplesof the computer readable medium 860 can include hard drives, networkattached storage, read-only memory, random-access memory, FLASH basedmemory, CD-ROMs, CD-Rs, CD-RWs, DVDs, magnetic tapes, other optical andnon-optical data storage devices, or any other physical or materialmedium which can be used to tangibly store the desired information ordata or instructions and which can be accessed by a computer orprocessor.

In some embodiments, the computer readable medium 860 can also bedistributed over a conventional computer network. For example, in someembodiments, the computer readable medium 860 can also be distributedover and/or accessed via the network interface 850 a. In this instance,computer readable code can be stored and executed in a distributedfashion using the computer system 800. For example, in some embodiments,one or more components of the system 800 can be tethered to send and/orreceive data through a local area network (“LAN”) 890 a. In some furtherembodiments, one or more components of the system 800 can be tethered tosend or receive data through an internet 890 b (e.g., a wirelessinternet). In some embodiments, at least one software module 880 runningon at least one processor 820 can be configured to be coupled forcommunication over a network 890 a, 890 b.

In some embodiments, one or more components of the network 890 a, 890 bcan include one or more resources for data storage and retrieval. Thiscan include any computer readable media in addition to the computerreadable medium 860, and can be used for facilitating the communicationof information from one electronic device to another electronic device.Also, in some embodiments, the network 890 a, 890 b can include widearea networks (“WAN”), direct connections (e.g., through a universalserial bus port), other forms of computer-readable medium 860, or anycombination thereof. In some embodiments, the software modules 880 canbe configured to send and receive data from a database (e.g., from acomputer readable medium 860 including data sources 870 a and datastorage 870 b that can comprise a database). Further, in someembodiments, data can be accessed and received by the software modules880 from at least one other source.

In some embodiments, one or more components of the network 890 a, 890 bcan include a number of user coupled devices 900 such personal computersincluding for example desktop computers, laptop computers, digitalassistants, personal digital assistants, cellular phones, mobile phones,smart phones, wearable technology devices (e.g. smart watches, activitymonitors, heart rate monitors), glasses, cameras, pagers, digitaltablets, internet appliances, and other processor-based devices. Ingeneral, a client device can be any type of external or internal devicessuch as a mouse, a CD-ROM, DVD, a keyboard, a display, or other input oroutput devices 870 c. In some embodiments, at least one of the softwaremodules 880 can be configured within the system 800 to output data to auser via at least one digital display. Further, in some embodiments,various other forms of computer-readable medium 860 can transmit orcarry instructions to a user interface such as a coupled device 900,including a router, private or public network, or other transmissiondevice or channel, both wired and wireless.

In some embodiments, the system 800 as described can enable one or moreusers 950 to receive, analyze, input, modify, create and send data toand from the system 800, including to and from one or more softwaremodules 880 running on the system 800. Some embodiments include at leastone user 950 accessing one or more modules, including at least onesoftware module 880 via a stationary I/O device 870 c through a LAN 890a. In some other embodiments, the system 800 can enable at least oneuser 950 accessing software module 880 via a stationary or mobile I/Odevice 870 c through an internet 890 a.

In some embodiments, the brace system or controller can comprisesoftware modules that are upgradeable. In some embodiments, the softwaremodules can be upgraded by an Internet download (for example through theInternet 890 a shown in FIG. 5). In some embodiments of the invention,the Internet download can comprise accessing at least one or moresoftware modules stored in a cloud-based storage location. In someembodiments, the brace system can access a cloud-based storage locationto perform periodic software updates and/or to store brace system data,and/or data from a brace system controller, and/or user data (i.e., datafrom a brace system attached to the user).

With the above embodiments in mind, it should be understood that someembodiments of the invention can employ various computer-implementedoperations involving data stored in computer systems (such as the system800 shown in FIG. 5). In addition, in some embodiments, theabove-described applications of the monitoring system can be stored oncomputer-readable storage media (such as computer readable medium 860).These operations are those requiring physical manipulation of physicalquantities. Usually, though not necessarily, these quantities take theform of electrical, electromagnetic, or magnetic signals, optical ormagneto-optical form capable of being stored, transferred, combined,compared and otherwise manipulated.

Any of the operations described herein that form part of the inventionare useful machine operations. The invention also relates to a device oran apparatus for performing these operations. The embodiments of theinvention can be defined as a machine that transforms data from onestate to another state. The data can represent an article, that can berepresented as an electronic signal and electronically manipulate data.The transformed data can, in some cases, be visually rendered onto adisplay, representing the physical object that results from thetransformation of data. The transformed data can be saved to storagegenerally or in particular formats that enable the construction ordepiction of a physical and tangible object. In some embodiments, themanipulation can be performed by one or more processors 820. In such anexample, the processors 820 can transform the data from one thing toanother. Still further, the methods can be processed by one or moremachines or processors that can be connected over a network. Eachmachine can transform data from one state or thing to another, and canalso process data, save data to storage, transmit data over a network,display the result, or communicate the result to another machine.Further, the brace system as described will result in a large quantityof data that must be manipulated, transformed, refined, reduced, orchanged from one state to another to be able to efficiently resolve intomeaningful segments of data that the user or clinician can utilize andmake medical based judgments upon. In one embodiment, the brace systemor controller includes software that performs a data collection andpre-filtering algorithm that stores data onto storage media only aftersome of the desired conditions have been met (e.g. the user is wearingthe brace and movement is occurring above/below a desired threshold, orROM data is captured only when user is vertical, or in periodic timepoints throughout the day such as once per minute or during user awakehours, etc.) In another embodiment, the computer system 800 performs thedata reduction and pre-filtering function. Computer-readable storagemedia (such as computer readable medium 860) as used herein, refers tophysical or tangible storage (as opposed to signals) and includeswithout limitation volatile and non-volatile, removable andnon-removable storage media implemented in any method or technology forthe tangible storage of information such as computer-readableinstructions, data structures, program modules or other data.

In some embodiments of the invention, the initiation of wireless datatransfer from and/or to the brace system (e.g., by using cellulartransfer of data) can be autonomous and/or semi-autonomous and can beconfigured to not require user configuration. For example, in someembodiments, the device can automatically check in when powered on. Insome embodiments of the invention, the brace system can include abackend system comprising one or more servers that are looking fordevices to check in at times for set usage. The backend system is thesystem of record for the patient compliance data. In some embodiments,if the device does not check in, the backend system or controller cansend a message the patient (or anyone else on a contact list) toindicate that device should be checked in.

Some embodiments of the invention can include uploading data to thebackend by coupling to a smart device or a computer. By way of example,in some embodiments, Bluetooth® products can be used to provide linksbetween any of the brace systems or assemblies described herein andmobile computers, mobile phones, portable handheld devices, wearabletechnology devices (e.g. smart watches, activity monitors, heart ratemonitors, glasses, cameras, etc.), personal digital assistants (PDAs),tablets, and other mobile devices and connectivity to the Internet. Insome embodiments, wireless transmission can occur via a Bluetooth®wireless signal from the brace system to the smart device or computer.In some embodiments, a user interface screen can be used to enablepairing of devices by using the Bluetooth® protocol. In some furtherembodiments, uploading data to the backend can occur by coupling to WiFito connect to the user's home network or office network. In someembodiments, this will require the creation of a user interface screenthat allows the user to select a wireless network to connect to and toprovide credentials to connect to that network.

In some embodiments of the invention, the brace system can utilizewireless protection schemes to control data access to and from the bracesystem. This can protect patient confidentiality and to protect thesecurity of the data. Some embodiments include protection againstunauthorized wireless access to device data and control. In someembodiments, this can include software and/or hardware enabled protocolsthat maintain the security of the communications while avoiding knownshortcomings of existing older protocols (including for example theWired Equivalent Privacy (WEP)). In some embodiments, usage data that istransmitted from the devices (via Bluetooth®, WiFi, or via other means)can be encrypted to ensure that only the patient or the patient'sphysician can obtain access to this medical information. The encryptioncan be done via either software executing on the processor or viaexternal hardware that processes the data before it is transmitted. Inone embodiment, each set of logs is uniquely tied to the device thatcreated them. This can be done by the device tagging the data beingtransmitted from the device with a unique identifier associated with thedevice. The unique identifier is set either by the processor or by anexternal component of the system (e.g., a UUID chip).

In some embodiments, the wireless collection can include wirelesscollection of compliance data. For example, in some embodiments, bracesystem data comprising a user's compliance to certain daily movementsand/or one or more physiotherapy or exercise routines can be wirelesslymonitored and recorded. In some embodiments, the brace system cancomprise a wireless collection of compliance data and can includecreation of a record of all instances that brace system sensordetermines a patient is wearing the brace system. In some embodiments,this can include stored data (e.g., data that has previously beenmeasured and stored in a volatile or non-volatile memory by the bracesystem). For example, this can include a wireless collection ofkinematic data, including data such as orientation data and accelerationdata. In some embodiments, the brace system can continue to store andtransmit data when the user is not wearing the brace system. In someembodiments, the data can be ignored, and in other embodiments, the datacan be stored and/or wirelessly transmitted. In some embodiments, thebrace system can wirelessly transmit data from the brace system to atleast one telemedicine system. In some embodiments, the brace system canwirelessly transmit data from the brace system to at least onephysiotherapist and/or physiotherapist system.

FIG. 6 illustrates an image of screen 950 showing the current status ofa brace assembly 960. In some embodiments of the invention, a bracesystem 951 can include a display screen 950 configured for projectingthe status of the brace system 951 including the brace assembly 960, anddisplaying a representation 965 of the degree of flexure and orientationof the brace assembly 960 relative to the ground. In some embodiments,the brace system 951 can render a display of the brace system 951substantially in real-time and can display graphical illustrations ordata pertaining to sensor data (e.g. usage trends, muscle strengthtrends, ROM trends, etc.) obtain from the brace assembly 960 (seedisplay portion 970 with trend data plot 975). In some embodiments ofthe invention, using one or more sensors, the brace system cancommunicate substantially in real time the position and movement of oneor more portions or sections of the brace system 951. This informationcan be processed by the system 951 for representation on the displayscreen 950 and/or for communication through a wired or wirelessconnection (e.g., such as a wireless data transfer data between the kneebrace assembly 670 and the controller 675 shown in FIG. 3B). In someembodiments, data collected by the brace system 951 can enable a medicalprofessional to adjust the brace system 951 based on this data. Forexample, the brace system 951 can measure muscle strength surroundingthe knee and/or the range of motion of the knee (e.g., obtained via anaccelerometer or positional encoder). The medical professional can thenutilize this feedback and data to adjust the treatment of the patientand/or adjust the brace system 951 based on these readings.

In some embodiments, one or more brace control programs can be selectedby a medical professional or patient that can be dynamic (e.g.,changeable or variable, not a fixed frequency, not fixed timing, not afixed waveform, etc.) and can cause different types of EMS to beexecuted on different parts of the patient's body. For example, if thefeedback data obtained and rendered by the brace system 951 from thebrace system's control electronics indicates that the patient's vastusmedialis oblique muscles are getting stronger while the patient's distalcentral hamstring (or, in another embodiment, the patient's calf muscle)is not getting stronger, a medical professional (e.g., physician orphysical therapist) can instruct, via one or more of these programs, thebrace system 951 to execute a predetermined brace control program. Insome embodiments, the brace system 951 can include specific programs forthe first week after surgery, specific programs for the first monthafter surgery, specific programs for arthritis, etc.

In some further embodiments, the motion of any portion of any of thebrace assemblies or systems described herein can be sensed. In someembodiments, at least one optical or other type of sensor can be coupledor integrated with the assemblies or systems for sensing motion and/orposition. For example, FIG. 7 shows a representation of brace system 980with kinematic data collections sensors 982, 984 in accordance with someembodiments of the invention. In some embodiments, one or morecomponents of the brace assembly 986 can be monitored by the sensors982, 984. FIGS. 8-9 provide representations of the potential motion ofvarious portions of the brace system that can be monitored in the bracesystem 950 represented in FIG. 7 (where brace system 980 representsbrace system 950). In some embodiments, an optical sensor (e.g., such assensors 982, 984) can be used in combination with a portion of the bracesystem 980 that includes an optically discernable region comprising anobserved region. For example, in some embodiments, one or more opticalsensors 982, 984 can be positioned to detect motion of a neighboringregion of the brace system 980 that comprises an observed region (i.e.,a region of the brace system that is sensed by the optical sensor). Insome other embodiments, one or more optical sensors 982, 984 can bepositioned to detect motion relative to a neighboring region of thebrace system that comprises an observed region (e.g., the portion of thebrace system comprising the observed region remains motionless and theportion of the brace system including the optical sensors can moverelative to the observed region). In some embodiments of the invention,the observed region can comprise an optically reflective material. Insome further embodiments, the observed region can comprise one or moremarkings capable of being detected by the one or more optical sensors.In some embodiments, observed region can comprise an optical emitter.For example, in some embodiments, one or more of the observed regionscan comprise an optical or infra-red LED. For example, in someembodiments, the position and/or movement of stay 987 can be monitoredby sensor 982. In some embodiments, the sensor 982 can comprise anoptical sensor, and the stay 987 can include optical encoders 987 a(e.g., tabs or marks that can be read or sensed by the sensor 982).Further, in some embodiments, the position and/or movement of stay 988can be monitored by sensor 984. In some embodiments, the sensor 984 cancomprise an optical sensor, and the stay 988 can include opticalencoders 988 a (e.g., tabs or marks that can be read or sensed by thesensor 984).

In some other embodiments of the invention, electrical sensing of motionof the brace system 950 can be used. For example, in some embodiments, acomponent of the brace system 950 (e.g., a hinge) can include anelectrical resistor and/or electrically resistive portion with anelectrical resistance that changes as a portion of the brace system 950moves. For example, in some embodiments, the electrical resistance canstart at a known value, and increase as the degree of openness of thehinge increases.

In some embodiments, one or more of the sensors 982, 984 can compriselinear, angular, rotary based position sensors/encoders. Someembodiments of the invention can comprise linear displacement sensorsthat are utilized on hinge bars to determine what length setting thepatient has selected. In some embodiments, positional sensors can beused to determine which ROM stops have been engaged, and compared towhat ROM limits should or should not be employed or if the extensionlockouts have been applied as prescribed. In some other embodiments, anyof the brace systems or assemblies (e.g., such as brace system 950)described herein can comprise force sensors, torque sensors, and/or adynamometer that can be integrated to determine the strength orforce/torque output of the joint and correlated to recovery of thepatient.

Conventional LAMES uses various dc, ac, and biphasic waveforms to inducemuscle response in human tissue. These can be either voltage or currentdriven and open or closed loop, and the amplitude of the wave can bedirectly controlled by the settings of the device. Electricalstimulation can also be used to reduce edema or swelling in the targettissues. FIG. 10 illustrates a sensor assembly 1000 for surface edemadetection through optical sensing in accordance with some embodiments ofthe invention. In some embodiments, the assembly 1000 can be used forregulating closed loop feedback for electrical stimulation therapies foredema. In some embodiments, an emitter/sensor assembly 1005 can beconfigured to emit red light from one or more LED's 1010 into thepatient's skin epidermis (1060) and dermis layers (1070), and detectingthe light signals and wavelengths (1085) reflected back from the skinusing one or more photodetectors (e.g., such as photo transistor 1020.)In some embodiments, the assembly 1000 can optically determine the levelof surface edema near the detector. Water has a characteristic opticalabsorption band that can be used to make this determination. In someembodiments, using output from this assembly 1000 in a closed loopfeedback manner can enable the electrical stimulation system to optimizestimulation parameters to achieve the desired level of edema reduction.Some embodiments include waveform modulation by setting a maximumcurrent to set the wave amplitude. Further, in some embodiments, twoseparate feedback loops can be used to modulate the wave (dynamicallyvary both current and voltage) to maintain constant power dissipation.The amplitude of the current and voltage waveforms can be changed, butnot the general shape of the waveform. In some embodiments, waveformscan build up on a carrier pulse of about 30 Hz to about 100 Hz andprovide a pulse block that is about 100 μs to about 10,000 μs wide. Someembodiments include a closed loop feedback mechanism. In someembodiments, the power supply can provide a high current low voltagesupply with multiple nested feedback loops that when summed create atime approximated constant power system. In some embodiments, the powersupply can maintain a constant power output, by trying to maintain thecurrent load of the system first, and the voltage load of the systemsecond. When the power supply output is summed over time, it can berelatively constant and based on the amplitude selected by the user inthe user interface.

In some embodiments, feedback can be collected on the back side of thefeedback loop, after it has passed through the user. Some embodimentsinclude control systems that are configured to maintain a constantoutput from the system. In some embodiments, the system can beconfigured to maintain a constant output as is passes through the user.In some embodiments, during the course of NMES, the conductiveproperties of a user's tissues change. In some embodiments of theinvention, the brace system can comprise a feedback loop thatcompensates for tissue changes by attempting to keep the outputconstant. As the resistance rises, the system can induce more current tokeep the power dissipation levels constant in the system. In someembodiments, if the resistance gets beyond a certain point the voltageof the system will spike to attempt to break through the high resistanceelement and allow current to flow.

Some embodiments of the invention can comprise systems for pain relief.In some embodiments, pain relief can be provided using electricalstimulation without the use of narcotics. In some embodiments, theelectrical stimulation can be provided by one or more electricalstimulators coupled to a user using a brace system. In some embodiments,a brace system can comprise at least one electrical stimulatorconfigured to provide electrical stimulation to provide pain relief tothe user. Nerves responsible for transmitting sharp pain send out anencoded burst of signals back to the autonomic nervous system. Theintroduction of a constant signal can disrupt the encoding of the painsignal and offer some pain relief. Some embodiments of the invention areconfigured to enable a user to self-tune the signal for maximumeffectiveness. In some embodiments, this can be achieved by varyingpulse amplitude, pulse width, and/or pulse duration. For example, FIG.11 illustrates a system 1100 for non-narcotic pain relief usingelectrical stimulation therapy to override pain impulses in accordancewith some embodiments of the invention. In some embodiments of theinvention, non-narcotic pain relief can be provided using electricalstimulation to override a pain impulse. In some embodiments, thenon-narcotic pain relief system can comprise a control unit 1105 coupledto epidermis 1103 via electrodes 1110, 1115 configured to provide acurrent flow 1120 through nociceptors 1125 of the user 1101.

Some embodiments of the invention can include systems configured forobtaining biological feedback. In some embodiments, biological feedbackcan be provided by one or more biological feedback sensors coupled to auser using a brace system. In some embodiments, one or more of the bracesystems or assemblies described herein can comprise at least onebiological feedback sensor configured to provide biological feedbackdata from a user. For example, in some embodiments, the human contactsensors shown in FIG. 2T can comprise one or more biological feedbacksensors positioned within the inner region of a brace. In someembodiments, these sensors can be proximity or contact sensors capableof determining if a device (e.g., such as a brace) is being worn by auser. Further, for example, electrical sensors can be included todetermine the impedance between sensors to determine if the device isattached to human skin. In some further embodiments, other sensors canbe used such as blood pressure sensors, blood oxygen level sensors,heart rate sensors, laser or ultrasound based sensors for measuringmovement of tissues or fluids, hydration sensors that measure theinterstitial fluid levels to determine hydration levels, force orpressure sensors for measuring the muscle activity/response, orelectromyography type sensors to measure muscle recruitment from theelectrical stimulation therapy, or to measure the level of musclefatigue. In some further embodiments, by measuring the hydration levelsof the user, the system can tune the electrical stimulation signals tobe more optimized or less painful for the user or provide feedback tothe user to drink more fluids.

In some further embodiments, the biological feedback sensor can compriseone or more temperature sensors. In some embodiments, one or moretemperature sensors can be coupled to or integrated with a brace system,and used to monitor temperature proximate the user. In some embodiments,one or more temperature sensors can be used in combination with NMEStherapy and used to sense temperatures proximate stimulation electrodes.In some embodiments of the invention, one or more temperature sensorscan be used in combination with NMES therapy and used for feedbackcontrol. For example, in some embodiments, the brace system can includea closed loop feedback system that provides electrical musclestimulation (EMS) to a joint of a human patient in response to feedbackfrom a sensed temperature. In some embodiments, the brace system caninclude one or more sensors in physical contact with the skin of thepatient and configured to obtain a sense and/or obtain information froma region of the skin and/or of a NMES electrode contacting the skin of apatient. For example, in some embodiments, one or more temperaturesensors can be used to sense temperature proximate one or more NMESelectrodes. In some embodiments, the brace system can also include bracecontrol electronics in communication with the sensor(s) to form a closedloop system via a combination of bracing the joint and electrical musclestimulation (EMS). Further, in some embodiments, the brace controlelectronics can be configured to receive temperature measurements of theskin of the patient and/or of one or more of the electrodes, and isfurther configured to instruct the sensor to apply acurrent/voltage/power onto the skin based on the temperature. Forexample, NMES can be reduced or increased based at least in part atemperature measurement from the one or more temperature electrodes. Insome embodiments, using one or more temperature sensors to sensetemperature proximate one or more NMES electrodes, where the sensedtemperature is used for control of NMES, NMES burns can be substantiallyreduced or eliminated. In some further embodiments, one or moretemperature sensors sensing changes in a user's body and/or body coretemperature can be used to estimate a user's activity level, or thepresence of an infection.

Some embodiments of the invention include systems for monitoring for thepresence or concentration of at least one chemical, biochemical markeror other analyte. In some embodiments, analytes can include naturallyoccurring or synthetic compounds or molecules, and/or metabolites. Forexample, in some embodiments, the brace system can include a bloodoxygen sensor apparatus configured for measuring the oxygen content ofblood. In some embodiments, a brace system configured with blood oxygenmonitors can enable an assessment of blood pooling and can be used toprevention of deep vein thrombosis (DVT), and other potentially fatalevents such as pulmonary embolism, extremity edema, and so on. Forexample, an example of biological feedback collection is shown in FIG.12. Some embodiments include a blood oxygen sensor 1200 coupled with astimulation system that include at least two electrodes 1205, 1210.

In some further embodiments, one or more of the brace systems orassemblies described herein can include a sensor apparatus configuredfor measuring nicotine, nicotine metabolites, and/or other drugs or drugmetabolites including stimulants, depressants, hallucinogens, designerdrugs, and anabolic steroids. In some embodiments, at least one of thebrace systems or assemblies described herein can comprise one or moresensors configured to detect one or more of these substances in-vivo andto notify the healthcare professional since they may affect the healingand rehabilitation process. In some other embodiments, the brace systemcan be configured with sensors to detect the immediate environment of auser. For example, in some embodiments, nicotine from first-hand orsecond-hand smoke can be sensed using one or more brace system chemicalsensors and used to determine if the user may have smoked and/or hasbeen exposed to high levels of tobacco smoke.

In some embodiments, any of the brace systems or assemblies describedherein can include at least one sensor configured to measure aheart-rate of a user. For example, in some embodiments, at least oneheart rate sensor can be used to determine if patients are performingprescribed exercises and/or physical therapy. Further, in someembodiments, at least one heart rate sensor can be used to determine auser's overall activity level (used for healing and data correlation).In some further embodiments, lung and/or breath sensors can be used toprovide data for a VO₂ max calculation, and provide additional data onactivity level. In some embodiments, the brace system can include atleast one heart-rate sensor integrated with a portion of a brace. Inother embodiments, the brace system can include at least one heart-ratesensor coupled to and adjacent to or some distance from the brace.

Some embodiments of the invention can comprise a non-invasive bloodpressure sensor configured to measure arterial blood pressurecontinuously or intermittently. In some further embodiments, a user'sheart-rate can be measured in addition to sensing the user's bloodpressure. In some embodiments, one or more of the brace systems orassemblies described herein can include at least one blood pressuresensor integrated with a portion of a brace. In other embodiments, thebrace system can include at least one blood pressure sensor coupled toand adjacent to or some distance from the brace.

In some further embodiments of the invention, some one or more of thebrace systems or assemblies described herein can comprise anelectromyography sensor, a strain gage sensor or other sensor configuredto measure strains continuously or intermittently. In some embodiments,these measurements can be used to assess motion, deflection, or providequantifiable data of muscle growth, muscle contraction, or forces,torques or pressures resulting from a muscle contraction. The musclecontraction may be voluntary or involuntarily elicited via electricalmuscle stimulation. In some embodiments, the data collected from theelectromyography sensor or strain gage sensor can be utilized in aclosed loop feedback control methodology in order to optimize/customizethe electrical stimulation parameters to provide the most efficient orstrongest muscle contraction for that patient. The data can also beutilized by the healthcare provider to fine tune the treatment programsbased on the patient's data captured from the electromyography or straingage sensor.

Some embodiments of the invention can include a brace system or assemblydescribed herein that can include at least one smart electrode. Forexample, FIG. 13 illustrates a smart electrode 1300 in accordance withsome embodiments of the invention. In some embodiments, at least one ofthe brace systems, assemblies, or methods described herein can compriseone or more smart electrodes 1300 that can comprise a temperatureresponsive color change pigment that can be used to determine if theelectrode has experienced an overheated condition. In some embodiments,the temperature responsive color change can be used to determine if theelectrode has been heated past a point that would cause a dielectricbreakdown of the electrode material. The degradation of a stimulationelectrode through dielectric breakdown can produce an unsafe electrodebecause of a change in the electrical characteristics, and a degradedelectrode of this type should not be used on a person. In someembodiments, any color change within the smart electrode 1300 can beused to signify whether the electrode is safe to use or whether theelectrode should be replaced. In some embodiments, the color change canalso be used to indicate to the physical therapist whether the electrodemay have potentially resulted in a skin burn or to allow the physicaltherapist to select electrical stimulation settings that produce energyoutputs below the temperature threshold where skin burns can occur. Someembodiments of the smart electrode 1300 can include a conductive siliconlayer 1310 including one or more sensors 1320 comprising a temperaturesensitive color change material mounted on a fabric base 1340. Further,some embodiments include a clear hydrogel layer 1330 covering at least aportion of the conductive silicon layer. The clear hydrogel layer 1330can provide physical protection to the sensor layer that is opticallytransparent to enable detection of the one or more sensors. In someother embodiments, the conductive silicon layer can be replaced byalternative conductive or semi-conductive layers, including PCB, HDMI,conductive glass layers, conductive polymer layers, ceramic layers, andso on. In some other embodiments, an optical sensor or photo detectorelement) can be included to detect color change in the smart electrode.In some embodiments, this automation can be accomplished by including acolor detection sensor that is placed directly on and/or proximate theelectrodes surface where it can be configured to monitor the color of atleast a portion of the electrode. In some embodiments, the color sensorcan be coupled to a controller to monitor changes to a color of theelectrode that denotes an unsafe electrode operational condition forhuman use. In some embodiments, the color sensor can be used by thesystem to identify the change and to disable the output of the systemafter the change is detected. Further, in some embodiments, the colorchange can be detected automatically and can be used in a closed-loopfeedback fashion to optimize electrical stimulation parameters toprevent excessive temperatures and patient burns from occurring duringelectrical stimulation.

In some embodiments of the invention, at least one of the brace systemsor assemblies described herein can include at least one adaptiveelectrode. For example, FIG. 14A-14C illustrates adaptive electrodes1400, 1425, 1450 in accordance with some embodiments of the invention.In some embodiments, the adaptive electrodes can be placed relative toone or more muscles to provide stimulation. In some embodiments, theelectrode can comprise a flexible PCB layer (shown as layer 1450), alayer comprising an array of silicon pads (layer 1425), and a hydrogellayer (layer 1400). Some embodiments include electrode clusters thatcontain a plurality of individual electrodes (e.g., such as electrodescomprising the layers 1400, 1425, 1450). In some embodiments of theinvention, the brace system can self-tune by allowing current to passthrough a selective number or all of the electrodes. In someembodiments, electrode selectivity can comprise sets with the lowestpower dissipation, with greater conductor performance, that can be anindicator of being aligned with muscle fibers or with muscle motorpoints. Further, by splitting a single electrode into a collection ofelectrodes it can be possible to provide improved distribution ofcurrent as applied to the surface of a user's skin. Moreover, currentelectrodes have the highest current density around the edge of theirpads, and the use of an adaptive electrode as described can effectivelytile the electrodes to distribute current out of hot zones, and over alarger area to improve user comfort and to prevent skin burns.

In some further embodiments of the invention, the brace system cancomprise one or more electrodes that comprise a circuit board located atthe electrode. Some embodiments of the invention include systems andmethods for using an SPI communication from the controller tocommunicate to a set gate at the electrode site. Further, the set gatecan determine which section of the electrode produces effectiveelectrical stimulation signals. In some embodiments of the invention,one or more electrodes and/or an array of electrodes can include aplacement of electrodes configured for a specific stimulation pattern tocause the muscles of a given limb to contract in a pattern that willintroduce blood flow in the tissue of that limb or to reduce edema inthat region.

Some embodiments of the invention include a brace system with integratedstimulation coupled with cold therapy or heat therapy. In someembodiments, the brace system can apply selective heat and cold therapythat can be delivered to limbs in braces using an embedded system thatcan change the internal temperature of at least a portion of the brace.In some embodiments, this can be achieved in conjunction with applyingstimulation to the selected limb. In some embodiments, the heatingand/or cooling can either be applied to the entire inside of the brace,or to selected locations inside of the brace. In some embodiments, thebrace system can comprise solid state heat exchangers that use thePeltier effect to directly heat or cool a specific location or region ofthe inside of the brace. Some embodiments of this system can use heatexchangers that are external to the brace. For example, in someembodiments, a system of tubes in a thermally conductive material cancirculate a fluid that is cooled by external heat exchangers. In somefurther embodiments, this system can use a phase change cooling materialto provide cooling to the entire inside of the brace, or to selectedlocations inside of the brace. In some embodiments, the system can use aphase change cooling material that freezes at 58° F., and does notreduce the temperature of the treated limb below a safe level.

Some embodiments of the invention can comprise a brace system thatprovides mechanical manipulation of the muscle to improve blood flow,and/or to prevent the formation of blood clots. Some embodiments of theinvention can use multiple air bladders that form concentric ringsaround a given limb. In some embodiments, if the pressure in these ringsis increased in successive rings that are in line with each other, aperistaltic pumping action can be introduced into the underlying tissuecausing an increase in the flow of blood in the tissue of the givenlimb.

Some embodiments include a shoulder vest or sling with integratedelectrical stimulation electrodes and inflatable bolsters that can beutilized to apply pressure to the electrodes for enhanced contact,conductivity and comfort with the skin. In some embodiments, inflationof an air bladder can be selectively applied and electronicallycontrolled as a method to improve contact pressure of the electrode andresulting comfort for the user without mechanical repositioning of theelectrode. Further, in some embodiments, a pump, and/or an expanding gasand/or fluid system (e.g., comprising a bladder) can be used forelectrode compression. Further, in some embodiments, the inflatablebolsters can be utilized to increase or reduce pressures on specifictissues for patient comfort during exercising, sleep, or otheractivities. For example, an inflatable bolster can be applied posteriorto the shoulder joint complex during sleeping and inflated manually bythe user to provide pain relief and comfort while lying down.

Some embodiments include a brace system with an integrated pressuretherapy system. For example, in some embodiments, an integrated pressuretherapy system can be used to treat deep vein thrombosis, as well asperform general compression therapy. For example, in some embodiments,using inflatable bolsters or bladders in combination with selectivelyapplied and electronically controlled actuation, the brace system canfunction as a pressure therapy system. In some embodiments, thispressure therapy system can be combined with electrical stimulationelectrodes and system to provide a comprehensive tissue treatmentsystem. Further, in some embodiments, the pressure therapy system can becombined with the electrical stimulation system and combined with theapplication of heat/ice temperature therapy to provide a comprehensivetissue treatment system.

FIGS. 15-22 show oscilloscope scan data of NMES under variousstimulation conditions produced using at least one of the brace systemsor assemblies described herein. For example, referring initially to FIG.15, illustrating an NMES post-operative oscilloscope scan 1500 of pulsetrains, the scan illustrates a pulse train view with a pulse trainduration of 3 sec, a work cycle of 13 sec on/10 sec off with verticaldivisions of 20V and horizontal divisions of 5 sec. The electricalstimulation pulses shown are monophasic pulses at a rate of about 50pulses per second with a 5 ms pulse width, 25% duty cycle, and under a500 ohm load with power level set at 100 on the device. As shown, thepulse trains oscillate between channels (e.g. muscle groups) over timeand do not overlap. In some embodiments, the pulse trains are anextended time of 3 seconds in order to better allow the patient tocoordinate voluntary contraction with the electrically stimulatedcontraction to restore volition.

FIG. 16 illustrates an NMES post-operative oscilloscope scan 1600 of achannel's individual pulses in accordance with some embodiments of theinvention illustrating a waveform view with vertical divisions of 20V,horizontal divisions of 5 milliseconds (hereinafter “ms”). Themonophasic pulses are applied at a rate of about 50 pulses per second,with a 5 ms pulse width, 25% duty cycle, under a 500 ohm load and withthe device power level set at 100. The waveform shown is not a typicalwaveform seen during electrical stimulation, as it is not a standardsquare, sinusoidal, triangular, sawtooth, or other waveform. Thewaveform shown is a complex waveform that has a high voltage spike onthe leading end which quickly transitions to a lower voltage saddlefollowed by an increase in voltage towards the end of the pulse. Thewaveform is illustrative of the closed loop feedback power control thatthe system employs, as it quickly responds to the desired power deliveryand current flow per the device settings. The voltages are much lowerand the pulse widths much longer than conventional NMES electricalstimulation parameters. FIG. 16 is illustrative of the electricalstimulation pulse targeted towards the Vastus Medialis Oblique (VMO)muscle group. FIG. 17 is similar to FIG. 16 and illustrates the scan1700 with waveform targeted towards the Rectus Femoris (RF) musclegroup. In some embodiments, this waveform is identical to the VMO, butin other embodiments, this waveform is modified and different foroptimal stimulation of both muscle groups.

FIG. 18 illustrates an NMES strength oscilloscope scan 1800 of pulsetrains in accordance with some embodiments of the invention. Itillustrates a pulse train view showing pulse train duration of 1 secwith a work cycle of 12 sec on/10 sec off. The vertical divisions are20V, and the horizontal divisions are 5 sec. The view illustratesmonophasic pulses at a rate of 50 pulses per second with 5 ms pulsewidth, 25% duty cycle, under a 500 ohm load and with device power levelset at 100. As can be seen in the oscilloscope scan, the pulse trainsoscillate between channels (e.g. muscle groups) over time and do notoverlap. The pulse train of 1 second allows a sustained contraction timethat is similar to contraction lengths that the patient would experienceduring exercise.

FIG. 19 illustrates a scan 1900 with view of the electrical stimulationpulse waveform with vertical divisions of 20 V, and horizontal divisionsof 5 ms. It illustrates a monophasic pulse at a rate of 50 pulses persecond with 5 ms pulse width, 25% duty cycle, under a 500 ohm load andwith device power level set at 100. The waveform shown is not a typicalwaveform seen during electrical stimulation, as it is not a standardsquare, sinusoidal, triangular, sawtooth, or other waveform. Thewaveform shown is a complex waveform that has a high voltage spike onthe leading end which quickly transitions to a lower voltage saddlefollowed by an increase in voltage towards the end of the pulse. Thewaveform is illustrative of the closed loop feedback power control thatthe system employs, as it quickly responds to the desired power deliveryand current flow per the device settings. The voltages are much lowerand the pulse widths much longer than conventional LAMES electricalstimulation parameters. FIG. 19 is illustrative of the electricalstimulation pulse targeted towards the Vastus Medialis Oblique (VMO)muscle group. FIG. 20 is similar to FIG. 19 and illustrates a scan 1900with the waveform targeted towards the Rectus Femoris (RF) muscle group.In some embodiments, this waveform is identical to the VMO, but in otherembodiments, this waveform is modified and different for optimalstimulation of both muscle groups.

FIG. 21 illustrates a TENS oscilloscope scan 2100 of a pulse train inaccordance with some embodiments of the invention. FIG. 21 illustrates apulse train view with vertical divisions of 20 V and horizontaldivisions of 10 ms. The electrical stimulation pulse is a biphasicsymmetric pulse at a rate of 100 pulses per second with 1 ms pulsewidth, 20% duty cycle, under a 500 ohm load and with device power levelset at 50.

FIG. 22 illustrates a TENS oscilloscope scan 2200 of individual pulsesin accordance with some embodiments of the invention. This figureillustrates a view of the electrical stimulation pulse waveform withvertical divisions of 20 V and horizontal divisions of 2.5 ms. Theelectrical stimulations pulse is a biphasic symmetric pulse at a rate of100 pulses per second with 1 ms pulse width, 20% duty cycle, under a 500ohm load with device power level set at 50. The waveform shown is not atypical waveform seen during electrical stimulation, as it is not astandard square, sinusoidal, triangular, a sawtooth, or other waveform.The waveform shown is a complex waveform that has a high voltage spikeon the leading end which quickly transitions to a lower voltage rampdown at the end of the pulse. The waveform is illustrative of the closedloop feedback power control that the system employs, as it quicklyresponds to the desired power delivery and current flow per the devicesettings. The voltages are much lower and the pulse widths much longerthan conventional TENS electrical stimulation parameters.

As described earlier, some embodiments of the invention can includebrace systems or assemblies that include a controller 675 coupled to acomputer system or device such as a personal computers and/or a smartphone. When coupled as a therapy control system, one or more functionaland/or operational aspects of a wearer's brace system or assembly can becontrolled or monitored through a graphical user interface (“GUI) usingthe computer system or device. For example, FIG. 23 illustrates adisplay 2300 of a therapy system control GUI in accordance with someembodiments of the invention. In some embodiments, the display 2300 caninclude an introduction and start menu or process to encourage andenable a user to couple, pair or synchronize, and/or register a braceassembly for use, and/or to review help information, including text,audio, video, and/or other media files. Further, the display 2300 caninclude one or more selectable actions or steps from which a user canselect to couple, pair, and/or register the brace assembly, or to accesshelp information as described. For example, in some embodiments, step2310 can include a “locate barcode” selector that a user can optionallyselect to initiate delivery of help information for display on the GUIand/or for delivery of audio information (e.g., such as verbalinstructions) to sound generator coupled to the user's computer systemor device. In some further embodiments, step 2320 can be used to selectan in-application scanner to scan and synchronize a brace or braceassembly comprising a garment. In some further embodiments, step 2330can be used to add further documents to the system and associatedapplications. In other embodiments, alternative optionally selectablesteps or processes can be used in place of steps 2310, 2320, 2330,and/or further optionally selectable steps can be included.

In some embodiments, if a user selects step 2310, a media window candisplay instructions for barcode location. For example, FIG. 24illustrates a display 2400 of a therapy system control GUI in accordancewith some embodiments of the invention. In some embodiments, the display2400 can include media window 2410 within which can be displayedinformation related to location of a garments barcode. The informationcan include text, graphics, video, still images or a combinationthereof. In some embodiments, audio information can be played in placeof or in addition to text, graphics, video, still images or acombination thereof.

In some embodiments of the invention, a user can download a therapycontrol application into a wireless device (e.g., such as a mobile phoneor smart phone). In some embodiments, the user can sets up a profile,and can then pair the application to the user's brace to commencestimulation and/or range of motion treatments using the user's GUI. Forexample, in some embodiments of the invention, the user's GUI can beused to initiate, direct, or monitor Bluetooth® enabled pairing orcoupling of one or more components of the therapy control system. FIG.25 illustrates one embodiments of display 2500 of a therapy systemcontrol GUI in accordance with some embodiments of the invention. Insome embodiments, the display 2500 can include at least one indicator2510 showing or indicating the status of a synchronization with a user'sgarment. In some embodiments, the display 2500 can include step 2520 toenable a user to activate Bluetooth®. Further, in some embodiments, step2530 can be used to synchronize with a mobile device.

FIG. 26 illustrates a display 2600 of a therapy system control GUI inaccordance with some embodiments of the invention. In some embodiments,the display 2600 can include media window 2610 within which can bedisplayed information related to Bluetooth® synchronization. Theinformation can include text, graphics, video, still images or acombination thereof. In some embodiments, audio information can bedisplayed in place of or in addition to text, graphics, video, stillimages or a combination thereof.

FIG. 27 illustrates a display 2700 of a therapy system control GUI inaccordance with some embodiments of the invention. In some embodiments,display 2700 can include a visual icon 2710 encouraging a user to pair auser's garment with a user's device using a selector bar 2720. In someembodiments, information bar 2730 can display the status of theBluetooth® coupling between the user's garment and device. Further, FIG.28 illustrates a display 2800 of a therapy system control GUI inaccordance with some embodiments of the invention. In some embodiments,display 2800 can include information bar 2810 indicating an errorconnection.

In some embodiments of the invention, the GUI can provide guidance foruse of a garment. For example, FIG. 29 illustrates a display 2900 of atherapy system control GUI in accordance with some embodiments of theinvention. In some embodiments, information display 2910 can query auser regarding help for fitting garment. Further, an associated visualicon 2920 can provide a display of a garment with which the user mayneed assistance or guidance with fitting, and selector bar 2930 canprovide a user with optional access to a help display. For example, FIG.30 illustrates a display 3000 of a therapy system control GUI inaccordance with some embodiments of the invention. In some embodiments,the display 3000 can include an information bar 3010 with one or moreinstructions, and information segment 3030 can include instructions forfitting. Further, visual indicator 3020 can include a visual display oftext, graphics, video, still images or a combination thereof showing orillustrating one or more steps of a fitting procedure for a garment. Insome embodiments, audio information can be played in place of or inaddition to text, graphics, video, still images or a combinationthereof.

In some embodiments, a selector bar 3040 can be used to exit help oradvance to another help step or subject. For example, FIG. 31illustrates a display 3100 of a therapy system control GUI in accordancewith some embodiments of the invention. In some embodiments, display3100 can include information bar 3110 indicating help for alignment ofelectrodes. Further, visual indicator 3120 can include a visual displayof text, graphics, video, still images or a combination thereof showingor illustrating one or more steps of a fitting procedure for aligningelectrodes. In some embodiments, audio information can be played inplace of or in addition to text, graphics, video, still images or acombination thereof.

FIG. 32 illustrates a display 3200 of a therapy system control GUI inaccordance with some embodiments of the invention. In some embodiments,display 3200 can include information bar 3210 indicating help forsecuring brace straps. Further, visual indicator 3220 can include avisual display of text, graphics, video, still images or a combinationthereof showing or illustrating one or more steps of a fitting procedurefor securing brace straps. In some embodiments, audio information can beplayed in place of or in addition to text, graphics, video, still imagesor a combination thereof.

FIG. 33 illustrates a display 3300 of a therapy system control GUI inaccordance with some embodiments of the invention. In some embodiments,a display 3300 can include information bar 3310 indicating instructionsfor plugging in the garment controller. Further, A visual indicator 3320can include a visual display of text, graphics, video, still images or acombination thereof showing or illustrating one or more steps ofplugging in the garment controller. In some embodiments, audioinformation can be played in place of or in addition to text, graphics,video, still images or a combination thereof.

In some embodiments, the GUI can be used to activate the garment. Forexample, FIG. 34 illustrates a display 3400 of a therapy system controlGUI in accordance with some embodiments of the invention. In someembodiments, the display 3400 can include information or action bar 3410signifying garment activation. In some embodiments, information segment3420 can include instructions or information related to garmentactivation status or procedures. In some embodiments, the visualindicator 3425 can include an illustration of the garment requiringactivation, and action selector 3430 can include a test garment actionicon 3430.

In some embodiments of the invention, the GUI can enable a user to testa garment. For example, FIG. 35 illustrates a display 3500 of a therapysystem control GUI in accordance with some embodiments of the invention.In some embodiments, display 3500 information related to the status ofvarious aspects of the user's garment. For example, in some embodiments,function 3515 can include an indicator 3515 a related to Bluetooth®connection status. Further, function 3520 can include an indicator 3520a related to the connection of a controller. Display portions 3600 and3650 shown in FIG. 36 illustrate different Bluetooth® status andconnection states. For example, display portion 3600 includes status3610 indicating Bluetooth® connection is in process, and display portion3650 includes status 3625 indicating controller connection is inprocess.

FIG. 37 illustrates a display 3700 of a therapy system control GUI inaccordance with some embodiments of the invention. In some embodiments,the display 3700 can include help icon 3710 to enable a user to accessone or more help information sections (e.g., such as those describedearlier). The display 3700 can also include access bar 3725 includingvarious function or access icons. For example, a home icon 3750 can beused to direct to a home page of the GUI. Further, stimulator icon 3760or range of motion icon 3770 can be used by a user to select treatment.For example, the stimulator icon 3760 can be used to access one or morefunctions or status of a stimulator coupled or integrated with theuser's garment, and the range of motion icon 3770 can be used to begintreatment designed to enhance a wearer's range of motion. Further, themenu icon 3780 can enable a user to access additional goals andapplication preferences.

In some embodiments, the GUI can enable to set goals for treatment. Forexample, FIG. 38 illustrates a display portion 3800 of a therapy systemcontrol GUI in accordance with some embodiments of the invention. Insome embodiments, the display 3800 can include a goal section 3810, setstimulation goal section 3825 including a range of motion goal section3827. In some embodiments, the goal section 3910 can include one or moreicons referring to areas of treatment. For example, icon 3815 cancomprise a reference to knee treatment, and icon 3820 can include areference to shoulder treatment. In some embodiments, the setstimulation goal 3825 section can include advice related to the goal andbenefits of the goal, including advised methods of treatment. In someembodiments, the range of motion goal 3827 can include a date selector3830 configured to enable a user to select a treatment date. In someembodiments, an exercise setting display 3832 can include a moveableindicator 3832 a for setting a user's target goal related to a bodyportion displayed as icon 3834. For example, referring to goals relatedto a user's selection of icon 3815 for knee treatment, exercise settingdisplay 3832 can include a moveable indicator 3832 a for setting auser's desired target extension angle. Further, exercise setting display3836 can include a moveable indicator 3836 a for setting a user's targetgoal related to a body portion displayed as icon 3838. In this instance,the exercise setting display 3836 can include a moveable indicator 3836a for setting a user's desired target flexion angle. Further, FIG. 39illustrates a display portion 3900 of a therapy system control GUI inaccordance with some embodiments of the invention. In some embodiments,the display 3900 can include information chart 3850 with goals selectedby the user including goals as a function of date as selected by dateselector 3830. For example, in some embodiments, user defined flexion,extension, and range of motion goals can be displayed as a function ofdate.

Some embodiments enable the user to increase the number of goals. Forexample, in some embodiments, pain reduction goals section 3860 can beused to set target pain reduction goals. In some embodiments, this canbe set as a function of date as defined using date selector 3860 a. Insome embodiments, a pain gauge 3870 can be used to set a target level ofpain using moveable indicator 3872. Further, the pain gauge 3870 caninclude a plurality of icons 3875 representing levels of pain from nopain, to moderate pain, to worst pain. Further, in some embodiments,action indicator 3878 can be used to add a goal, and action selector3890 can be used to set a goal. In some embodiments, display 3879 caninclude a display of goals displayed as a function of date 3880 and painlevel 3885. At any time, access bar 3892 can be provided to enable auser to access other functions of the system.

FIG. 40 illustrates a display portion 4000 of a therapy system controlGUI in accordance with some embodiments of the invention. In someembodiments, the display 4000 can comprise a drop down menu 4010configured for selection of a date range, and FIG. 41 illustrates acorresponding display portion 4100 of a therapy system control GUI inaccordance with some embodiments of the invention.

FIG. 42 illustrates a display portion 4200 of a therapy system controlGUI in accordance with some embodiments of the invention. In someembodiments, the display portion 4200 can include a selector 4220configured to enable a user to switch between goals and achievements. Insome embodiments, icons 4230 can display one or more body portionsrelated to goals or achievements, and goal and achievements display 4240can include a display of target goal 4245 versus actual achievements4250 as function of therapy type 4260 and date 4270 (e.g., such asdaily, weekly, and/or monthly goals). In some embodiments, the goal andachievements display 4240 can configure as goals and achievementsdisplay 4340 with a daily comparison of goals and achievements (e.g.,see FIG. 43 and display portion 4300). FIG. 44 illustrates a display4400 of a therapy system control GUI in accordance with some embodimentsof the invention, and displays a monthly version of the goal andachievements display 4240 (shown as goal and achievements display 4440).

FIG. 45 illustrates a display portion 4500 of a therapy system controlGUI in accordance with some embodiments of the invention. In someembodiments, the display portion 4500 can comprise an achievementdisplay 4510 (with selector toggle 4505 set to achievements), whereaward section 4515 can include one or more achievement awards based onthe user reaching or exceeding specific or non-specific goals. Awardsection 4515 can include awards for stimulation goals. FIG. 46illustrates a display portion 4600 of a therapy system control GUI inaccordance with some embodiments of the invention, and shows awardsrelated to flexion (awards display 4610), extension (awards display4620), and range of motion (awards display 4630). FIG. 47 illustrates adisplay portion 4700 of a therapy system control GUI in accordance withsome embodiments of the invention, and includes awards display 4715 withawarded awards 4720, and FIG. 48 illustrates a display portion 4800 of atherapy system control GUI in accordance with some embodiments of theinvention, and includes awards display 4810, awards display 4820, andawards display 4830. FIG. 49 illustrates a display portion 4900 of atherapy system control GUI in accordance with some embodiments of theinvention, and includes awards display 4915 with awards 4918, and FIG.50 illustrates a display portion 5000 of a therapy system control GUI inaccordance with some embodiments of the invention, and shows awardsdisplay 5015, awards display 5020, and awards display 5025.

FIG. 51 illustrates a display 5100 of a therapy system control GUI inaccordance with some embodiments of the invention. In some embodiments,display 5100 can comprise an announcements or information display 5110configured to display therapy status (e.g., such as number ofstimulations completed). In some embodiments, an award indicator 5120can be displayed based on the display therapy status.

FIG. 52 illustrates a display 5200 of a therapy system control GUI inaccordance with some embodiments of the invention. In some embodiments,display 5200 can be displayed based on a user's selection of access bar3725. In some embodiments, the display 5200 can include a help icon 5210to enable a user to access one or more help menus. The display 5200 canalso include a garment selector 5220 that can be optionally selected bya user to add additional garments to a stimulation session. Further, insome embodiments, a battery indicator 5230 can be used to show batterycharge of the user's device. Stimulation pulse activity can also bemonitored. For example, FIG. 53 illustrates a display 5300 of a therapysystem control GUI in accordance with some embodiments of the invention.In some embodiments, the display 5300 can include pulse currentindicator 5310 and/or pulse level indicator 5320.

FIG. 54 illustrates a display 5400 of a therapy system control GUI inaccordance with some embodiments of the invention. In some embodiments,display 5400 can comprise a timer 5410 that can display time left in atherapy session. Further, some embodiments include a pause selector 5420configured to enable a user to pause a therapy session.

In some embodiments, the GUI can be configured with various help menusthat enable a user to select from various help topics. For example, FIG.55 illustrates a display 5500 of a therapy system control GUI inaccordance with some embodiments of the invention. In some embodiments,the display 5500 can comprise a dashboard help section 5510 thatincludes a menu 5525 that can enable a user to select one or more helpsubjects. Further, FIG. 56 illustrates a display 5600 of a therapysystem control GUI in accordance with some embodiments of the invention.In some embodiments, the display 5600 can include a pin management helpsection 5610 that can include a menu 5620 configured with selectabletopics related to pin management.

FIG. 57 illustrates a display 5700 of a therapy system control GUI inaccordance with some embodiments of the invention. In some embodiments,the display 5700 can include a menu 5710 configured with selectablepreferences. Further, FIG. 58 illustrates a display 5800 of a therapysystem control GUI in accordance with some embodiments of the invention.In some embodiments, the display 5800 can include a menu 5810 configuredwith user selectable profile help topics. FIG. 59 illustrates a display5900 of a therapy system control GUI in accordance with some embodimentsof the invention. In some embodiments, the display 5900 can comprise atopic title 5910, and a menu 5920 can include one or more questionsrelated to the topic. The visual window 5930 can include a visualoverview of the therapy, and information segment 5940 can includeinstructions, advice, or other information related to the therapy.Further, FIG. 60 illustrates a display 6000 of a therapy system controlGUI in accordance with some embodiments of the invention. In someembodiments, display 6000 can include a range of motion test help 6010including a menu 6020 configured for selection of at least one helptopic.

FIG. 61 illustrates a display 6100 of a therapy system control GUI inaccordance with some embodiments of the invention. In some embodiments,the display 6100 can comprise a range of motion help 6110 including amenu 6120 comprising a one or more selectable help topics. Further, FIG.62 illustrates a display 6200 of a therapy system control GUI inaccordance with some embodiments of the invention. In some embodiments,the display 6200 can include a pause stimulation help 6210 including amenu 6220 comprising one or more help topics related to stimulation.Further, FIG. 63 illustrates a display 6300 of a therapy system controlGUI in accordance with some embodiments of the invention. In someembodiments, the display 6300 can include a pause stimulation help 6325including a menu 6330 comprising one or more help topics related tostimulation.

FIG. 64 illustrates a portion of a stimulation circuit 6400 of a therapycontrol system in accordance with some embodiments of the invention. Insome embodiments, the circuit 6400 can comprise at least one resistor6450 coupled in parallel with at least one capacitor 6460 coupled toground. In some embodiments, this configuration enables a comfortablestimulation pulse when delivered to a wearer.

FIG. 65A illustrates a display 6500 of a therapy control system inaccordance with some embodiments of the invention. In some embodiments,the display 6500 can enable a user to enter and/or review personalinformation within an information window 6510, including, but notlimited to height, weight, date of birth, and gender. Further, FIG. 65Billustrates a display 6550 of a therapy control system in accordancewith some embodiments of the invention. In some embodiments, the display6550 can include an information window 6560 that includes at least someof the user's health information. For example, in some embodiments,certain specific information can include information regarding aprevious surgery related to current or pending therapy provided by thetherapy control system.

In some embodiments, a user can select a garment type and initiateconnection to the garment. For example, FIG. 66 illustrates a display6600 of a therapy control system in accordance with some embodiments ofthe invention. In some embodiments, the display 6600 can include agarment type 6610 from which a user can select and add one or moregarments for use in one or more therapy sessions. Using Bluetooth®connect 6620, a user can connect to the one or more garments to commencea therapy session. Further, FIG. 67 illustrates a display 6700 of atherapy control system include a scrolled portion of the display 6600illustrating background information window 6710. In some embodiments, auser can scroll the information window 6710 to access different portionsof the window 6710.

In some embodiments, a user can monitor and track therapy sessions usinga dashboard. For example, FIG. 68 illustrates a display 6800 of atherapy control system including a dashboard 6810. In this examplefocused on knee therapy, a progress bar 6820 can comprise the status oftherapy including the number of and type of completed or in-progresstherapy sessions, and/or the number and type of pending or plannedtherapy sessions. Further, in some embodiments, one or more access tabscan enable a user to access various therapy session or programs, sessionor program settings, or data recorded during any session or program. Forexample, some embodiments include stimulation tab 6830, and/orROM/flexion/extension tab 6840, pain indicator tab 6850, and stepsindicator tab 6860.

Some embodiments include a display of therapy settings that can beconfigured or reconfigured by a user. For example, FIG. 69 illustrates adisplay 6900 of a therapy control system in accordance with someembodiments of the invention. In some embodiments, the display 6900 caninclude a therapy session window 6910 including one or more therapysettings or controls. For example, some embodiments include a thigh areadial 6920, and/or a knee area dial 6930, and/or an area three dial 6940,and/or an area four dial 6950. In some embodiments, any of the dials6920, 6930, 6940, 6950 can include controls to enable a user to increaseor decrease one or more therapy parameters represented by the dials6920, 6930, 6940, 6950.

Some embodiments can include a visual or graphical display during atherapy session. For example, FIG. 70 illustrates a display 7000 of atherapy control system in accordance with some embodiments of theinvention. In some embodiments, the display 7000 can include a visualguide 7010 providing an anatomical representation of a portion of auser's body undergoing therapy. In some embodiments, the visual guide7010 can include therapy parameters 7020 from the user includingflexion, and/or extension, and/or range of motion data. In some furtherembodiments, the therapy parameters 7020 can be tracked and plotted overtime. For example, FIG. 71 illustrates a display 7100 of a therapycontrol system in accordance with some embodiments of the invention. Insome embodiments, the display 7100 can include a therapy progress plot7110 illustrating flexion, and/or extension, and/or range of motion dataplotted as a function of time. Further, in some embodiments, a detailssection 7120 can comprises tabulated data of flexion, and/or extension,and/or range of motion data, alongside pain data. Referring to FIG. 72,some further embodiments include a display 7200 with a therapy progressplot 7210 showing progress represented as average power. The display7200 can also include a therapy dates section 7220 to enable a user todisplay the plot 7210 with a selected data range. Further, sessiondetails section 7230 can include tabulated session data including thestart and end time of the therapy session, and the average power fromthe session.

In some embodiments, a user can monitor pain based on timing, sessionactivity or other desired parameters. For example, FIG. 73 illustrates adisplay 7300 of a therapy control system in accordance with someembodiments of the invention. In some embodiments, the display 7300 caninclude a therapy pain plot 7305 comprising before session pain, and/orafter session pain, and/or a daily average pain level. Further, asession details section 7310 can include tabulated pain data as afunction of session date.

In some other embodiments of the invention, a user's steps can bemonitored and displayed. For example, FIG. 74 illustrates a display 7400of a therapy control system in accordance with some embodiments of theinvention. In some embodiments, the display 7400 can comprise a therapysteps plot 7405 comprising steps as a function of time, with sessiondetails section 7410 providing tabulated steps as a function of date.

As described earlier with respect to FIGS. 3A and 3B, some embodimentsinclude various electronic components can be integrated into one or moremodules of a brace system, and the modules can be combined andrecombined into various configurations. For example, FIG. 75 illustratesa therapy system 7500 that includes a garment 7510 including acontroller 7520 integrated or coupled to the garment 7510. Further, someembodiments include one or more sensor pods 7525 integrated or coupledto the garment 7510. In some embodiments, the controller 7520 includesrechargeable power storage. Further in some embodiments, the sensor podincludes onboard power.

In some embodiments, one or more sensor pods 7525 can be linked to thecontroller 7520 using a wired or wireless link. For example, in someembodiments, one or more sensor pods 7525 can be linked to thecontroller 7520 using a Bluetooth® wireless link. In some embodiments,one or more of the sensor pods 7525 can exchange data with thecontroller 7520, which can exchange the data, or related data to auser's device such as mobile device 7530. Further, in some embodiments,the mobile device 7530 can exchange the data or related data to anexternal server system 7540 (e.g., such as a cloud server and/or storagesystem). In some embodiments, the controller 7520 can be configured toexchange information with the one or more of the sensor pods 7525 andthe mobile device 7530 at substantially the same time. Referring to FIG.76, illustrating data types 7600 for the therapy system of FIG. 75 inaccordance with some embodiments of the invention, in some embodiments,exchanged data can include stimulation data 7610, and/or range of motiondata 7630, and/or pain data 7660, and/or activity level data 7690. Insome embodiments, the stimulation data 7610 can include information ordata from one or more therapy sessions, and/or therapy power levels,and/or power level changes, and/or treatment types, and/or stimulationcomfort. In some embodiments, the range of motion data 7630 can includerange of motion, and/or flexion, and/or extension information or dataonce daily (or over other time times). In some embodiments, this datacan enable passive monitoring and gait analysis. In some furtherembodiments, the pain data 7660 can include pre and post stimulationpain levels measured and/or distributed at least three times on a dailybasis or over other time periods. In some other embodiments, theactivity level data 7690 can include the number of steps, accelerationsand velocity data.

Some embodiments of the invention analyze activity level data 7690comprising gait phases using one or more of ROM, accelorometers,gyroscopes, and EMG. Such gait phase analyses can compare post-injury orpost-training data to pre-injury, pre-therapy or pre-training baselinedata to better evaluate rehabilitation and/or training progress. Gaitanalyses can also be used alone or with other biometric analyses toidentify patients in some embodiments.

In some embodiments, EMG signal and force relationship analyses can alsohelp evaluate rehabilitation and training progress. Some embodimentsprovide customized therapy and/or training based on feedback from thegait phase or EMG signal and force analyses. In some embodiments, EMGsignals are evaluated alternately with stimulation therapy. In someother embodiments, EMG signals are evaluated simultaneously withstimulation therapy using conventional signal filtering and analysistechniques. Finally, in some embodiments, surface EMG analyses can beused to diagnose muscle and/or neurological disease characteristics.

FIG. 77 illustrates data categories 7700 exchanged between and storedwithin components of the therapy system of FIG. 75 in accordance withsome embodiments of the invention. For example, some embodiments includeserver data categories 7710 comprising data or information exchangedbetween and/or stored on a server such as where the mobile device 7530can exchange the data or related data to an external server system 7540(e.g., a cloud server and/or storage system). Some embodiments alsoinclude mobile device application data categories 7740 comprising dataexchanged between and/or stored on the a user's device such as mobiledevice 7530. Further embodiments include garment controller datacategories 7770 comprising data exchanged between and/or stored on agarment controller such as controller 7520. In some embodiments, any ofthe data categories can include a read/write access setting restrictingaccess or providing a level of access. In some embodiments, theread/write access protocols and method of data transfer can be set HIPAAcompliance.

In some embodiments, a healthcare provider can log into a physicianportal of the system (website or software application, mobile app, etc.)In some embodiments, the website can allow the provider to register foran account. In some embodiments, the website can allow a provider to adda device (patient) to his patient list via a unique device ID. In someembodiments of the invention, the website can interact with a cloudserver to display a physician's patient data. In some embodiments, aportal dashboard can allow a healthcare provider to view his/herpatients or the group's (healthcare practice's) patients. In someembodiments, the system can allow a healthcare providers to customizecriteria for categorizing patients (e.g., usingred/yellow/green/excluded category types), etc. In some embodiments, thesystem can utilize push alerts (email, SMS, secure messages, etc.) viacustomizable criteria sent to healthcare provider to notify if patient'sprogress is outside of desired zones or at risk for re-admissions. Forexample, FIG. 78 illustrates a portion of a provider portal dashboard7800 including categorization of patients based on physiciancustomizable criteria so that physician can receive alerts based onhis/her preferences. For example, a compliance summary for a patient caninclude an example embodiment such as an “ok” compliance alert that iscolored green. In a further embodiments, a “warning” alert can becolored yellow. In another embodiment, a “critical” alert can be coloredred, and an “excluded” alert can be colored black or grey. One ofordinary skill in the art can recognize that other colors, images,graphics, animations, or combinations thereof can be used to representthe compliance summary.

FIG. 79 illustrates a customizable panel and alerts window 7900 of theprovider portal dashboard in accordance with some embodiments of theinvention. In some embodiments, the window 7900 can comprise acustomization panel for categorization & alerts including, but notlimited to, a monitoring (time) window (pre-op, post-op, etc.), and/orusage/compliance rates, and/or ROM, and/or extension, and/or painvalues.

In reference to FIG. 80, some embodiments include a provider portalpatient list window 8000 that can be used to provide a patient list withvisible flags indicating categorization of patients based on provider'scustomized criteria. In some embodiments, the provider portal patientlist window 8000 can include an ability to search/filter/sort records,and/or to add devices/patients to a patient list. In some embodiments,the window 8000 can be customized to provide a “my patients” view and/ora “group patients” view.

Some embodiments include a graphical view of longitudinal data for apatient with graphical and/or tabular data for ROM. For example, FIG. 81illustrates a patient overview window 8100 in accordance with someembodiments of the invention. (e.g., including flex/ext/ROM degrees),and/or NMES/TENS stimulation (power levels, # sessions), and/or painlevels (e.g., vas scale), and/or activity levels (e.g. steps), and/orpatient reported outcome measures (PROMs), such as KOOS/KOOS JR/HOOS JR,etc., and/or rehabilitation goals. Further, FIG. 82 illustrates atabular view of a patient overview window 8200 with tabulatedlongitudinal data for that patient. In some embodiments, the windows8100, 8200 can include graphical/tabular toggles to enable switching orrotating between graphical and tabular data views. In some embodiments,the system can enable the generation of printable patient overviewcharts. For example, FIGS. 83A-83B, and 84A-84B illustrate patientoverview printable charts in accordance with some embodiments of theinvention. Some embodiments include formatted charts for printing orexporting, saving to PDF, saving to electronic health record (EHR/EMR),etc.

In some embodiments, the system can display graphical and tabular datasimultaneously. For example, FIG. 85 illustrates a patient stimulationdetail window 8500 in accordance with some embodiments of the invention.In some embodiments, the window 8500 can include a detailed graphicaland tabular view of longitudinal stimulation data. In some embodiments,the window 8500 can include power levels by zone, and/or the number ofcompleted sessions, and/or the stimulation time, and/or the number ofsessions per week, and/or the last session details, and/or anyyellow/green flags based on customizable settings. FIG. 86 illustrates apatient range-of-motion (ROM) detail window 8600 in accordance with someembodiments of the invention. Some embodiments include detailedgraphical and tabular view of longitudinal ROM data, including, but notlimited to flexion (degrees), extension/hyper extension (degrees),and/or ROM (degrees). Other embodiments can include the number ofsessions, and/or the last measurement details. Further embodiments caninclude colored flags (e.g., such as red/yellow/green flags) based oncustomizable settings.

Some embodiments include a detailed graphical and tabular view oflongitudinal pain data that includes average pain values (vas—visualanalog scale), and/or pre/post stimulation session data, and/or lastmeasurement details, and/or red/yellow/green flags based on customizablesettings. For example, FIGS. 87-88 illustrate patient pain detailwindows 8700, 8800 in accordance with some embodiments of the invention.Further, some embodiments can include a detailed graphical and tabularview of longitudinal activity data including average daily steps and/orlast measurement details.

Some embodiments include passive range of motion data. For example, FIG.89 illustrates patient passive range of motion (PROM) 8900 in accordancewith some embodiments of the invention. Some embodiments include adetailed graphical and tabular view of longitudinal PROMs data,including, but not limited to KOOS/KOOS JR, HOOS/HOOS JR, VR-12, patientsatisfaction surveys. Some embodiments include category and compositescores, data viewed by survey time point(s), and/or latest measurementdetails.

Some embodiments include a real-time rehabilitation and tracking system.For example, in some embodiments, a patient can download a mobileapplication and pair a rehabilitation system to one or more personalmobile devices. For example, any of the brace systems or assemblies thatcan capture range of motion (hereinafter “ROM”) described earlier can bethe rehabilitation system that can be paired to the mobile devices. Insome embodiments, the mobile device application can serve as a userinterface to operate a device via Bluetooth®. In some embodiments, therehabilitation system can perform NMES/TENS stimulation, and/or measureROM, and/or record pain levels, and/or record activity levels, and/oradminister patient reported outcome measures (PROMs) per desiredtime-points. In some embodiments, the mobile device can transmit alldata up to system cloud servers via WiFi or cellular data (usage data,measurements, patient profile information, etc.).

Various display screen content produced by the real-time rehabilitationand tracking system is shown in FIGS. 90A-98. For example, FIG. 90Aillustrates start mobile application screen 9000 in accordance with someembodiments of the invention. In some embodiments, the screen 9000 caninclude a visual static or animated display of a representation of auser turning on one or more components or assemblies of the real-timerehabilitation and tracking system. For example, in some embodiments, apatient can be shown as accessing and turning on a brace system orassembly and any barcode or specification information.

Further, FIG. 90B illustrates scan mobile application screen 9050 inaccordance with some embodiments of the invention. In some embodiments,the screen 9050 can include an illustration of scanning a garmentcomprising the rehabilitation and tracking system. In some embodiments,following a successful device scan, the device can display aninformation screen. For example, FIG. 90C illustrates an informationmobile application screen 9075 in accordance with some embodiments ofthe invention. FIG. 91A illustrates a start stimulation mobileapplication screen 9100 in accordance with some embodiments of theinvention. In some embodiments, the screen 9100 can include informationrelated to therapy type and recommendations.

FIG. 91B illustrates a dashboard mobile application screen 9150 inaccordance with some embodiments of the invention. In some embodiments,the screen 9150 can include access icons for home, stimulator, ROM, andmenu. In some embodiments, the screen 9150 can include a daily progressdisplay showing progressive sessions. In some embodiments, access tabscan be provided that are configured to access stimulation history,and/or ROM/flexion-extension, and/or pain, and/or steps. In someembodiments, the user can use the screen 9150 to reversibly access oneor more of the access tabs using the screen 9150 as the main or controlscreen.

FIG. 92A illustrates a stimulator session start mobile applicationscreen 9200 in accordance with some embodiments of the invention. Insome embodiments, the screen 9200 can include an indication of thesession number of type, and/or an indication of the body part receivingtherapy and/or can provide information on the therapy such as therapytime, and/or the recommended times and/or days or dates of therapy.

FIG. 92B illustrates a pain survey mobile application screen 9225 inaccordance with some embodiments of the invention. In some embodiments,the screen 9225 can include a stimulation survey and can display aselectable gauge of pain level. In some embodiments, the screen 9225 canbe shown prior to initiation of a stimulation session. In someembodiments, the system can display options for treatment programs priorto initiation of treatment. For example, FIG. 92C illustrates astimulation treatment mobile application screen 9250 in accordance withsome embodiments of the invention. In some embodiments, the screen 9250can display a selection option of a “post-op” program and/or a“strength” program.

Some embodiments include a stimulation alert window. FIG. 93Aillustrates a stimulation level information mobile application screen9300 in accordance with some embodiments of the invention. In someembodiments, a prompt can be displayed to urge a user to proceed whenthe user us ready to commence therapy. FIGS. 93B-93C, and 94A illustratestimulation level mobile application screens 9325, 9350, 9400 inaccordance with some embodiments of the invention. In some embodiments,the screens 9325, 9350, 9400 can include an indication or display of asession number or type, and/or at least one stimulation level selectoror indicator. In some embodiments, the stimulation level selector orindicator can comprise a toggle to increase or decrease the stimulationlevel and an indicator showing the stimulation level and/or a numericindicator of the stimulation level. As shown in FIG. 94A, someembodiments include a timer display for the therapy session. In someembodiments, the stimulation can be stopped or paused. For example, FIG.94B illustrates a stimulation information mobile application screen 9450shown after pausing a therapy session.

Some embodiments include display screens illustrative of ROM therapy.For example, FIG. 95A illustrates a range of motion (ROM) start mobileapplication screen 9500 in accordance with some embodiments of theinvention. In some embodiments, the screen 9500 can include a static oranimated display of a ROM exercise and an access or start icon to enablea user to start a ROM test. FIG. 95B illustrates a range of motion (ROM)connecting mobile application screen 9525 in accordance with someembodiments of the invention. In some embodiments, the screen 9525 caninclude a display showing a ROM image or animation to enable a user tovisualize a ROM. In some embodiments, the screen 9525 can include adisplay of flexion, and/or extension, and or ROM. FIGS. 95C and 96Aillustrate a range of motion (ROM) measuring mobile application screen9550, 9600 in accordance with some embodiments of the invention. In someembodiments, the screen 9550, 9600 can include a ROM image or animationto enable a user to visualize a ROM measurement. FIG. 96B illustrates arange of motion (ROM) results mobile application screen 9625 inaccordance with some embodiments of the invention. In some embodiments,the screen 9625 can include a display of ROM based on one or more ROMtherapy sessions. In some embodiments, the screen 9625 can include a ROMdisplay of a goal ROM, and can include a goal flexion and/or extensionangle.

FIG. 97A illustrates a settings mobile application screen 9700 inaccordance with some embodiments of the invention. In some embodiments,the screen 9700 can include a settings display comprising one or moreselectable or adjustable settings. For example, some embodiments includea selectable toggle for “complete stimulation”. Some further embodimentsinclude a selectable toggle for “complete range of motion”. Some furtherembodiments include a selectable toggle for “replace electrodes”. Somefurther embodiments include a selectable toggle for “complete myprofile”. Some other embodiments include a range of motion adjustment.In some embodiments, any of the selectable or adjustable settings can beselected to display one or more selectable icons, and/or data fields.For example, FIG. 97B illustrates a profile mobile application screen9725 in accordance with some embodiments of the invention. In someembodiments, the screen 9725 can include one or more selectable icons,and/or data fields related to a user's profile.

FIG. 97C illustrates a set your goals mobile application screen 9750 inaccordance with some embodiments of the invention. In some embodiments,the screen 9750 can include information related to one or more goals,and/or one or more selectable icons, and/or data fields related to auser's goals. FIG. 98 illustrates a stimulation help mobile applicationscreen 9825 in accordance with some embodiments of the invention. Insome embodiments, the screen 9825 can include one or more help topicsrelated to stimulation or other therapy related procedures or actions.

It will be appreciated by those skilled in the art that while theinvention has been described above in connection with particularembodiments and examples, the invention is not necessarily so limited,and that numerous other embodiments, examples, uses, modifications anddepartures from the embodiments, examples and uses are intended to beencompassed by the claims attached hereto. The entire disclosure of eachpatent and publication cited herein is incorporated by reference, as ifeach such patent or publication were individually incorporated byreference herein. Various features and advantages of the invention areset forth in the following claims.

The invention claimed is:
 1. A system comprising: at least one sensorcomprising a plurality of electrodes including at least one activeelectrode and at least one receiving electrode, the at least one sensorconfigured and arranged to be in physical contact with skin of a patientforming an electrical circuit with control electronics of at least onecontroller, the electrical circuit configured and arranged to measure anelectrical parameter using the at least one active electrode and atleast one receiving electrode, and to form a closed loop electricalmuscle stimulation system, wherein a stimulation current or voltageapplied by the sensor onto the skin between the at least one activeelectrode and at least one receiving electrode is based on at least oneprogram and at least one electrical parameter measured through the atleast one active electrode and at least one receiving electrode, the atleast one controller configured and arranged for (a) applying a senseelectrical pulse to the tissue using the at least one sensor, (b)measuring the at least one electrical parameter from the tissue, (c)using at least one of the active electrodes, adjustably applying astimulation pulse to the tissue based at least in part on the measuredelectrical parameter, the stimulation being adjustably controlled by theat least one controller to maintain a constant power output to thetissue based at least in part on the at least one electrical parameter,and (d) repeat steps (a)-(c); and a good coupled to at least onecomputer readable medium configured to store usage data, the usage datarelating to the patient's use of the good.
 2. The system of claim 1,further including a computing program, applet or application configuredto upload usage data for analysis.
 3. The system of claim 2, wherein theat least one controller is configured and arranged toelectromagnetically couple with a mobile computing device using at leasta portion of the computing program, applet or application.
 4. The systemof claim 3, wherein at least a portion of the computing program, appletor application is configured and arranged to include at least one userinterface on a user's computing device, the at least one user interfaceconfigured to display at least some usage data and to enable control ofa parameter of the good.
 5. The system of claim 4, wherein the at leastone controller is configured to update the at least one user interfacewith at least one of a status of a portion of the good, a position of aportion of the good, and data from the at least one sensor.
 6. Thesystem of claim 4, wherein the at least one user interface comprises adisplay including an option to scan and synchronize the good with the atleast one controller.
 7. The system of claim 4, wherein the at least oneuser interface comprises a display including an option to scan andsynchronize more than one good.
 8. The system of claim 4, wherein the atleast one user interface comprises a display including an option toactivate a wired or wireless link to connect the good with the at leastone controller.
 9. The system of claim 6, wherein the display isconfigured and arranged to enable the user to set or reconfigure the atleast one stimulation pulse.
 10. The system of claim 6, wherein thedisplay is configurable by the at least a portion of the computingprogram, applet or application to display one or more parameters relatedto at least one of stimulation provided by at least a portion of thegood, and a range of motion measured by at least a portion of the good.11. The system of claim 6, wherein the display is configurable by the atleast a portion of the computing program, applet or application toprovide a visual representation of an action of a user wearing at leasta portion of the good that is related to at least one of stimulationprovided by at least a portion of the good, and a range of motionmeasured by at least a portion of the good.
 12. The system of claim 4,wherein the computing device comprises at least one of a desktopcomputer, a laptop computer, a digital tablet, a digital assistant, acellular or smart phone, a smart watch, a wearable activity monitor, apair of glasses, a camera, a pager, and an internet appliance.
 13. Thesystem of claim 1, wherein the good comprises a brace assembly.
 14. Thesystem of claim 13, wherein the brace assembly comprises at least one ofa brace, a stay, a sleeve, a band, a sling, a garment, a wrap, and astrap.
 15. The system of claim 1, wherein the at least one sensorcomprises at least one of an accelerometer, a motion sensor, a proximitysensor, an optical sensor, a motion sensor, a gyrometer, a magnetometer,a proximity sensor, a hydration sensor, a force or pressure sensor, aposition sensor, a global positioning sensor (GPS), an optical sensor, amagnetic sensor, a magnetometer, an inductive sensor, a capacitivesensor, an eddy current sensor, a resistive sensors, a magnetoresistivesensor, an inductive sensor, an infrared sensor, an inclinometer sensor,a piezoelectric materials or piezoelectric-based sensor, a blood-oxygensensor, a heart-rate sensor, a laser or ultrasound based sensor, and anelectromyography type sensor.
 16. The system of claim 1, furthercomprising a remote server including a computing program, applet orapplication configured to initiate or maintain an exchange of the usagedata between the good and the server and/or a coupled mobile computingdevice and the server.
 17. The system of claim 16, wherein the server isconfigured as a host to a web portal or coupled to a host serverproviding the web portal, the web portal configured to access or displaythe usage data or at least one parameter related to use of at least aportion of the good.
 18. The system of claim 17, wherein the web portalis configurable to create one or more alerts based on at least one usercustomization criteria related to the usage data, wherein the criteriacan include at least one of a level of use of at least a portion of thegood by a user, a limit of use of at least a portion of the good by theuser, a time of use of at least a portion of the good by the user, atype of use of at least a portion of the good by the user, and abehavior of at least a portion of the good while in use by the user. 19.The system of claim 18, wherein the alert comprises at least one of anemail, a text or SMS message, a displayed icon, rendered text, arendered graphic, a categorized or customized alert.
 20. The system ofclaim 18, wherein the at least one user customization criteria includesat least one of a monitoring window, usage rate and/or activity level,one or more specified compliance or rehabilitation goals, compliancerate, range of motion (ROM), and pain values.